In November, the most popular stories from Interventional News included stories from our latest issue concerning the global lack of interventional radiology (IR) devices for paediatric patients; an international heatmap of IR's progression to primary specialty; a study which...
Summa Therapeutics, a specialty angioplasty balloon medical device company, has announced that its innovative line of injectable angioplasty balloon catheters has been cleared for marketing by the US Food and Drug Administration (FDA) for the treatment of peripheral artery...
BD, a leading global medical technology company, have launched a new advanced ultrasound system designed to help improve clinician efficiency when placing peripherally inserted central catheters (PICCs), central venous catheters, IV lines and other vascular access devices.
The SiteRite 9...
Transit Scientific, a Utah-based medical device company specialising in innovative solutions for vascular procedures, has announced the US Food and Drug Administration (FDA) clearance of its microcatheter designed for the precise delivery of a broad range of embolic agents....
Fluidx Medical has released information about their new ULTRA embolic platform designed to make therapeutic embolization procedures safer, better, and faster, as the recent press release states.
Embolization is a minimally invasive catheter-based procedure that blocks blood flow to targeted...
Clinical professor of radiology Mishal Mendiratta-Lala (Michigan, USA), expands on the first data release from the #HOPE4LIVER trial, presented during the FIRST@CIRSE session at this years Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting.
“We are very excited about...
OncoSil Medical, a medical device company focused on localised treatments for patients with locally advanced pancreatic cancer (LAPC) announces the first patient has been treated in the PANCOSIL investigator initiated clinical trial on 28 November 2023.
The first patient...
Inari Medical has announced the first patient enrolment in PEERLESS II. This prospective, global, multicentre randomised controlled trial (RCT) compares the outcomes of intermediate-risk acute pulmonary embolism (PE) patients treated with the FlowTriever system against those treated with traditional...
Penumbra today announced that the first patient has been enrolled in STORM-PE, a prospective, multicentre, randomised controlled trial (RCT) evaluating anticoagulation alone versus anticoagulation plus Lightning Flash for the treatment of pulmonary embolism (PE).
In partnership with PERT Consortium,...
A recent study concerning moral injury (MI) among interventional radiologists has found that the condition is “prevalent” throughout the field, and has been shown to negatively correlate with quality-of-life (QoL) indicators.
Principal investigator Andrew J Woerner (University of Washington,...
A panel of leading experts has welcomed guidance published by the National Institute for Health and Care Excellence (NICE) recommending the use of hybrid closed loop systems for managing blood glucose levels in the management of type 1 diabetes...
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Thierry de Baère (Paris, France), Laurent Milot (Lyon, France) and Govindarajan Narayanan (Miami, USA) sit down for an Interventional News Expert Panel discussion on robotics in Interventional Oncology.
The...
Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium) at the Paris Vascular Insights (PVI) 2023 congress (8–10 November, Paris, France). The...
Inari Medical has announced that it has completed its acquisition of chronic limb-threatening ischaemia (CLTI) treatment maker LimFlow.
The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to US$415 million. The deal came just weeks...
New research to be presented at the Radiological Society of North America (RSNA; 26–30 November 2023, Chicago, USA) annual meeting has found that, by using an image-guided minimally-invasive procedure, patients suffering from long COVID can have their sense of...
Baird Medical, leading microwave ablation (MWA) medical device developer and provider in China, has announced that its subsidiary, Betters Medical, has received clearance from the US Food and Drug Administration (FDA) under Section 510k, to begin marketing its portfolio...
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“The advances led by this technology have significantly revolutionised our procedures,” states José Andres Guirola Ortiz (Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain), discussing how the “invaluable”...
The International Accreditation System for Interventional Oncology Services (IASIOS) has reported experiencing exponential growth exceeding 150% in the past year. IASIOS has been at the forefront of standardising interventional oncology (IO) care worldwide, with a mission to make it...
Cordis has announced the completion of patient enrolment in the RADIANCY premarket clinical study. The prospective, multicentre, single-arm study is designed to evaluate the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system when used with the Brite...
Lagging behind the rapid advancements within the speciality as a whole, a 2023 study titled ‘Is there really no kit for kids?’ has identified the continuing “unmet need” for paediatric interventional radiology (IR) devices. Although off-label device usage has...
Medtronic has announced approval from the USA Food and Drug Administration (FDA) for the Symplicity Spyral renal denervation (RDN) system for the treatment of hypertension. The company has said that it will immediately begin commercialisation following the approval.
“Medtronic has...
Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year's VEITHsymposium (14–18 November, New York, USA).
The SWING trial is a 35-patient...
Vivasure Medical has enrolled the 100th patient in its PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system.
The US Food and Drug Administration (FDA) granted investigational device exemption...
Over several decades, interventional radiology (IR) has scaled to significant heights, leading technological advancements and minimally-invasive techniques. As these milestones have been reached, however, historical pitfalls have deepened, prompting international discussion about the current structure of IR and the...
The Centers for Medicare & Medicaid Services (CMS) has released its final decision regarding National Coverage Determination (NCD) 20.7 covering carotid artery stenting (CAS), essentially confirming the coverage expansion outlined in July in a proposed decision memo.
CMS outlined in...
Liz Kenny of the Royal Brisbane and Women’s Hospital (Brisbane, Australia) gave her radiation oncologist’s take on the “120-odd-year” history of radiation therapy, how to plan it, and its delivery at the 2023 European Conference on Interventional Oncology (ECIO;...
Shape Memory Medical, developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE safety trial will be presented during the 50th annual VEITHsymposium (14–18 November, New York City, USA) on Tuesday, November 14,...
Interventional radiology (IR) is a main player in modern clinical oncology practice. Almost every tumour board has a seat for IR. Clinical oncology is a rapidly evolving field as well; new therapies are being introduced frequently allowing for treatment...
Presenting on machine learning (ML) to predict responders following prostatic artery embolization (PAE) at the British Society of Interventional Radiology (BSIR; 8–10 November 2023, Newport, UK) annual meeting, Ganesh Vigneswaran (University of Southampton, Southampton, UK) sets out his case...
Honoured as the British Society of Interventional Radiology (BSIR) travelling professor, Ian McCafferty (The Radiology Clinic, Birmingham, UK) gave the Graham Plant lecture at the BSIR annual meeting (8–10 November 2018, Newport, UK). Titled ‘Acute trauma intervention: Have we...
A new study published in BJS Open has found that revascularisation treatment to restore blood flow to the legs of patients with severely blocked arteries is no more expensive than carrying out an amputation.
The peer-reviewed paper is the first to compare...
Interventional radiologist and medical director for The Royal College of Radiologists, Raman Uberoi (The John Radcliffe Hospital, Oxford, UK), gave this year’s Andreas Gruentzig Lecture at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13...
Cordis has announced that its board of directors has appointed Scott Drake as chief executive officer (CEO) effective immediately. Drake most recently held the position of executive chairman of the Cordis board of directors. He will succeed Shar Matin,...
Obesity has been steadily increasing worldwide for at least 50 years. It directly contributes to the rising incidence of cardiovascular, musculoskeletal, and oncological diseases. Becoming one of the most concerning public health issues, obesity accounts for a majority of...
Recor Medical has become the first company in the USA to have a device-based therapy approved for the treatment of hypertension, after it was announced that the US Food and Drug Administration (FDA) has approved the company’s Paradise ultrasound...
Interventional News’ most read stories in October included significant data releases from TCT 2023 (23–26 October, San Francisco, USA); results from a study investigating sex disparities in outcomes post-TCAR; among several device updates.
1. Cryoablation found to “significantly reduce pain” in...
Interventional News is delighted to welcome professor of interventional radiology Robert Morgan (St George’s Hospital NHS Foundation Trust, London, UK) as editor-in-chief. Morgan is currently a clinical director for diagnostics at St George’s, clinical lead for the South West...
Patients diagnosed with benign bone tumours will be relieved to know that these are not malignant, and some tumours will involute spontaneously. However, this natural history can be unpredictable, and tumours can be associated with significant pain, pathologic fracture,...
Sirtex Medical, a leading manufacturer of interventional treatment solutions, has announced the commercial availability of the LAVA liquid embolic system, the first and only liquid embolic approved for the treatment of peripheral vascular haemorrhage.
LAVA provides volume and viscosity options...
The Duo venous stent system (Vesper Medical/Philips) showed a 98.7% freedom from major adverse events (MAEs) at 30 days and 90.2% primary patency at 12 months, results from the VIVID trial revealed.
The data—which covered 162 subjects with nonthrombotic, acute...
Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
A press release details that PTAB with the Detour system offers a novel approach to treating...
InspireMD recently presented 30-day results from the C-GUARDIANS US investigational device exemption (IDE) clinical trial evaluating its CGuard embolic prevention stent (EPS) system for stroke prevention at the annual Vascular Interventional Advances (VIVA) meeting (30 October–2 November 2023, Las...
Contego Medical has announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at the annual Vascular Interventional Advances (VIVA) meeting (30 October–2 November 2023, Las Vegas, USA). PERFORMANCE II is a prospective, multicentre study...
Interventional News 92 Highlights:
International IR voices map the path to primary specialty
Interventional News welcomes new editor-in-chief Robert Morgan
Profile: Jonathan Moss
CIRSE: Top stories from this year's Cardiovascular and Interventional Radiological Society of Europe 2023 annual meeting
CMS...
Interventional News 92 Highlights:
International IR voices map the path to primary specialty
Interventional News welcomes new editor-in-chief Robert Morgan
Profile: Jonathan Moss
CIRSE: Top stories from this year's Cardiovascular and Interventional Radiological Society of Europe 2023 annual meeting
Advertorial:...
Penumbra, a global healthcare company focused on innovative therapies, announced the latest STRIKE-PE data evaluating Penumbra’s Indigo aspiration system with Lightning. The results show Penumbra’s computer assisted vacuum thrombectomy (CAVT) is safe and effective at reducing right heart strain.
It...
LimFlow announced today that it has entered into a definitive agreement to be acquired by Inari Medical.
A press release details that, under the terms of the agreement, LimFlow will receive US$250 million in cash at closing and be eligible...
Surmodics has announced the commercial launch of its most advanced hydrophilic medical device coating technology, the Preside hydrophilic coatings.
As per a company press release, Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique,...
Endovascular Engineering (E2) has announced positive initial results from its ENGULF study, demonstrating successful outcomes among the first 15 patients evaluated in the trial using the Hēlo thrombectomy system for the treatment of acute sub-massive pulmonary embolism.
The ENGULF Study...
New research from the FLASH registry shines a light on the effectiveness of large-bore mechanical thrombectomy in managing high-risk pulmonary embolism. The study, titled "Mechanical thrombectomy for high-risk pulmonary embolism: Insights from the US cohort of the FLASH registry," provides valuable insights into this life-saving...
A recent publication in the journal Obstetrics & Gynaecology has reported an increase in the risk of hysterectomy after endometrial ablation from one to five years post-procedure.
The risk assessment was conducted by Tamara J Oderkerk (Maxima Medical Center, Eindhoven,...
David Dexter (Sentara Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry this week at The VEINS 2023 (28–30 October, Las Vegas, USA).
Long-term, prospective outcome data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking. The...
Muneeb Ahmed is an interventional radiologist specialising in interventional oncology (IO) at Beth Israel Deaconess Medical Centre (Boston, USA) and current president of the Society of Interventional Oncology (SIO). Speaking to Interventional News, Ahmed describes the nature of his...
Data from the REAL-PE study were presented this week at TCT 2023 (23–26 October, San Francisco, USA) demonstrating that patients treated for pulmonary embolism (PE) with the Ekos endovascular system (Boston Scientific) had lower rates of adverse events, including...
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Highlights:
Philippe Pereira (SLK-Clinics GmbH, Heilbronn, Germany) pairing OPTIQ with personalised, multidisciplinary oncological medicine, “we have a big and bright future”.
Bernhard Gebauer (Charité University Hospital, Berlin, Germany) expands on the “excellent effect”...
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“A dedicated, holistic venous approach is mandatory—including deep, superficial and pelvic venous systems,” says Houman Jalaie (University Hospital RWTH Aachen, Aachen, Germany), outlining what he believes was...
Thrombolex has announced never-before-reported major reductions in obstruction in all of the segmental pulmonary arteries (PA), based on independent core lab data analysis of 107 patients from 18 sites in the USA, with acute intermediate-risk pulmonary embolism (PE), using...
Results of the LIFE-BTK randomised controlled trial have just been presented at TCT 2023 (23–26 October, San Francisco, USA). The data show that, in patients with chronic limb-threatening ischaemia (CLTI) due to infrapopliteal artery disease, an everolimus-eluting resorbable scaffold...
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) saw presenters explore where thyroid thermal ablation treatments sit within practice today and how guideline recommendations worldwide have shifted to encompass the treatment...
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT...
ABK Biomedical, a medical device company dedicated to the research, development, and commercialisation of advanced imageable embolic medical devices, has announced the first patient treated in its Route90 US investigation device exemption (IDE) pivotal study. The Eye90 microspheres...
Robocath has today announced the results of its CARE clinical trial focusing on robotic carotid stenting—the first phase of a research programme launched in July 2021 by Robocath and Rennes University Hospital (Rennes, France), which, in the long term,...
Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform.
The company details in a press release that the FreedomFlow platform is designed with a modern mechanism...
Interventional Systems have announced that Micromate has been granted a new 510(k) clearance, allowing the commercial sale of the robotic system in the USA for percutaneous procedures using computed tomography (CT) optical navigation, such as biopsies and ablations, to...
Delcath Systems, an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, have announced the publication of an article entitled ‘Selective internal radiotherapy (SIRT) and chemosaturation percutaneous hepatic perfusion (CS-PHP) for metastasized uveal...
Published in the Journal of Vascular and Interventional Radiology, a recent retrospective study which evaluated pain relief after percutaneous image-guided cryoablation in patients with symptomatic extraperitoneal endometriosis (EE), has found the treatment to be “safe and effective”. Lead author...
New research examining the safety and efficacy of using radial access for peripheral artery interventions has found that radial access allows early ambulation and same-day discharge with no serious adverse events.
These are the conclusions of a study published in...
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The EffPac trial was a prospective, multicentre, randomised controlled trial (RCT) that enrolled 171 patients of Rutherford category two to four with medium-length femoropopliteal lesions. Patients...
While sex disparities regarding the outcomes of carotid revascularisation have “long been a concern”, new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid...
HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, has announced the marketing authorisation of its “breakthrough” platform via the US Food and Drug Administration's (FDA) de novo classification request process, a rigorous pre-market review...
“We wanted to find a common language between interventional radiologists and nephrologists and we wanted to be sure that the angioplasty we have done has a functional improvement”, associate professor of interventional radiology, Stavros Spiliopoulos (Athens, Greece) speaks to...
Merit Medical Systems, a leading global manufacturer and marketer of healthcare technology, today announced the expansion of its Maestro microcatheter product line to now include a new longer length for radial embolization procedures.
The Maestro is part of a comprehensive...
Roger Malcolm Greenhalgh, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on 6th October, aged 82. At the time of his death, he was emeritus Professor of Surgery at Imperial College...
Artivion has announced presentation of interim results from the Ascyrus medical dissection stent (AMDS) PERSEVERE clinical trial in a late-breaking science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (4–7 October, Vienna, Austria).
Fernando Fleischman (Keck...
Interventional News’ most read stories in September included first data releases from the this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) such as STRIKE-PE results; Laminate Medical announce FDA approval of...
Yuji Okuno (Tokyo, Japan), winner of the Award of Excellence and Innovation in Interventional Radiology during the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 meeting, discusses his pioneering work on the treatment of chronic musculoskeletal inflammation and...
MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront closing payment of US$200 million, together with regulatory achievement milestones of up to US$125 million and commercial milestones of up to US$775...
Laminate Medical Technologies has announced their flagship device, the VasQ External Vascular Support, has been cleared by the US Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the...
Shockwave Medical has announced that Nick West has joined the company in the role of associate chief medical officer (CMO). He will report to current CMO Keith Dawkins, and will be based in Santa Clara (USA) with plans to...
TechsoMed, a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VisAble.IO software intended to assist physicians in planning...
Presenting real-world population data in patients with pulmonary embolism (PE), John Moriarty (University of California, Los Angeles Medical Center, Los Angeles, USA) demonstrated results from the STRIKE-PE study at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE)...
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) played host to another FIRST@CIRSE session, which saw first data releases from various interventional radiology trials. Mishal Mendiratta-Lala (University of Michigan, West Bloomfield,...
Presenting data from the MOTIV bioresorbable scaffold (Reva Medical) below-the-knee (BTK) trial during Saturday’s FIRST@CIRSE session at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark), Thomas Rand (Klinikum Floridsdorf, Vienna,...
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark) hosted sessions dedicated to radiation protection, contemporary risk management strategies for staff and patients, and challenges faced by interventional radiologists in the developing...
Tze Tec Chong (Singapore General Hospital, Singapore) presented results from the PRISTINE registry at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark), which aimed to investigate the performance and safety of...
Christoph Binkert (Winterthur, Switzerland) and current president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) tells Interventional News about the three-fold focus and goals for interventional radiology (IR) in Europe, as defined by the society: clinical care;...
Raman Uberoi (Oxford, UK), who delivered this year’s Andreas Gruentzig Lecture at the CIRSE annual meeting told Interventional News: “We need to radically think about how we train future generations, how we support interventional radiologists to give them control over...
LimFlow, a developer of minimally-invasive technologies for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has announced that the US Food and Drug Administration (FDA) has approved the LimFlow system to help...
Biotronik has announced the two-year results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (Ghent University, Gent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen,...
Sirtex Medical, a leading manufacturer of interventional treatment solutions, has announced the establishment of a collaboration and exclusive worldwide distribution agreement with Magle Group, a Sweden-based contract development and manufacturing organization as well as degradable starch microspheres (DSM) sales...
This advertorial is sponsored by Interventional Systems.
Achieving consistency, accuracy, and ease of use in interventional radiology (IR) and interventional oncology (IO) procedures, including biopsy and ablation, while limiting procedure time, can present challenges for interventional radiologists. These range from...
The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations,...
Delcath Systems, an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, has announced that it raised approximately US$35 million through the exercise of all the Tranche A warrants issued as part the...
Interventional News’ most popular stories from August include a commentary on intra-arterial approaches to advanced pancreatic cancer; perspectives on 25 years of day-case IR in the UK; study results concerning high-dose dexamethasone for post-embolization syndrome in PAE; and a...
“The median thrombus age of DVT patients treated in our centre is 14 days – says Dr Andrew Wigham from Oxford University Hospitals. – We know that traditional treatment options such as thrombolytics and other thrombectomy devices are less...
The incidence of lung cancer has increased considerably in the last few decades with the lung as the most common site of metastatic involvement. Despite the improvements in the diagnosis and treatment for malignant lung tumours, the prognosis of...
In February 2023, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), in conjunction with the European Union of Medical Specialists (UEMS) Interventional Radiology (IR) division, published a new curriculum and syllabus, an update to the previous version released...
Ayman Al Sibaie is a consultant interventional radiologist currently working at Rashid Hospital (Dubai, UAE), and has been the president of the Pan Arab Interventional Radiology Society (PAIRS) since 2019. Interventional News interviewed him to delve into his practice...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices.
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling...
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A recent Inari Medical roundtable webinar examined how to build a venous practice effectively—three experts from different specialties discussed the importance of forming and maintaining internal and external networks; what to consider when...
This advertorial is sponsored by Terumo Interventional Systems.
Koen Deloose (Sint Blasius Hospital, Dendermonde, Belgium) talks to Interventional News about the importance of treating femoropopliteal disease patients and why some of the new generation bare metal stents are more advantageous...
This advertorial is sponsored by BD.
There has been major progress in the treatment of peripheral arterial disease (PAD) globally in the last few years, “but there are still issues that need to be addressed”, Marianne Brodmann (Medical University of...
Researchers behind a new study published in the Annals of Vascular Surgery, among them lead author Laura Anderson and corresponding author Benjamin Brooke (both University of Utah Health, Salt Lake City, USA), have found that severe obesity risks a...
When utilised as a first-line technique for medium vessel occlusion (MeVO) stroke, aspiration and stent-retriever thrombectomy have demonstrated “no significant difference” in imaging-related or clinical outcomes. That is according to a multicentre, propensity score-matched analysis including more than 400...
The use of catheter-based localised delivery of drugs for treatment of cancer patients has proven to be effective and provides the benefit of reduced systemic toxicity. A critical prerequisite for these modalities is the angiographic identification and engagement of...
The Society for Cardiovascular Angiography & Interventions (SCAI) has welcomed the review of scientific data related to the premarket approval applications for two renal denervation systems, describing this as a “step forward to advancing access to additional therapies for...
Boston Scientific has received 510(k) clearance for expanded indication of the Visual Ice cryoablation system. The clearance grants this device an indication expansion to now be used in the treatment of pain associated with tumours that have metastasised to...
Oluwatoyin (Toyin) Dada is a current fifth-year postgraduate trainee (resident) in interventional radiology (IR) and diagnostic radiology (DR), and Ariana Mills, a first-year resident. Both are based at the Icahn School of Medicine at Mount Sinai (New York City,...
Olivier Pellerin (Université de Paris, Paris, France) presented on technological updates in the renal space at the Global Embolization Oncology Symposium Technologies meeting (GEST; 18–21 May, New York City, USA). He set out to provide a “broad overview” of...
This advertorial is sponsored by BD.
Focusing on the disease through the patient’s lens, establishing well-functioning multidisciplinary teams, to potentially enhance both the patient’s journey and clinical outcomes got top billing at BD’s second EMEA End-Stage Kidney Disease (ESKD) Summit...
Interventional News 91 Highlights:
US Food and Drug Administration (FDA) removes red flag for paclitaxel-coated devices after review finds data do not support mortality risk
Letter from joint editor-in-chief Brian Stainken
New renal technologies: From radial access to angio-CT
...
Interventional News 91 Highlights:
US Food and Drug Administration (FDA) removes red flag for paclitaxel-coated devices after review finds data do not support mortality risk
Letter from joint editor-in-chief Brian Stainken
New renal technologies: From radial access to angio-CT
...
Interventional News began more than 20 years ago as an effort to better cover the global interventional space, selecting news stories and other content that is not the province of peer-reported journals, but still important to the practising interventionalist....
The International Accreditation System for Interventional Oncology Services (IASIOS), a membership-based accreditation programme, announces its continued advancement in a recent press release, reporting that their network has tripled since its 2021 inception.
The programme seeks to further establish interventional...
This advertorial is sponsored by Boston Scientific.
Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel safety. This central message from a Boston Scientific symposium at the recent Leipzig Interventional Course...
In 2010, the UK Royal College of Radiologists (RCR) with the Royal College of Paediatrics and Child Health (RCPCH) published a report focused on how to improve paediatric interventional radiology (PIR) services. In June 2023, an updated report was...
Yuji Okuno (Okuno Clinic, Tokyo, Japan) shared with delegate sat the European Conference on Embolotherapy (ET; 21–24 June, Valencia, Spain) an analysis of the best embolization approaches to certain sports injuries associated with overuse.
Okuno began his presentation by defining...
Erik Cressman (MD Anderson Cancer Center, Houston, USA) took to the podium, also at 2023 Global Embolization Oncology Symposium (GEST, 18–21 May, New York City, USA), to dive into why tumour ‘temperature’ matters—explaining what the terminology refers to, and its significance...
“Even , healthcare costs are spiralling, so we are also learning how to be prudent.” Farah Gillan Irani is an Indian-born and educated interventional radiologist who has practised in Singapore since 2009. She has been a principal investigator in...
Instylla, a company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the closing of a US$30 million financing round.
This financing round was led by new investor, Delos Capital, with continued participation from the investor syndicate of...
MedAlliance has announced completion of patient enrolment in the SAVE clinical trial with the Selution Sustained Limus Release (SLR) 018 drug-eluting balloon (DEB) for the treatment of failed arteriovenous fistulas (AVFs) in renal dialysis patients. Selution SLR is a...
Microbot Medical, the developer of the LIBERTY Robotic Surgical System, the first single-use endovascular robotic system, today announces the expansion of its global team of experts supporting the company as scientific advisory board (SAB) members, with Francois H Cornelis...
Xeltis has announced the closing of an additional €12.5 million in funding from the European Innovation Council (EIC) Fund, set up by the European Commission. Today’s extension from EIC and the closure of the Series D2 financing round announced in...
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“We need to eliminate symptoms as fast as possible—it is not OK just to make things a little better,” says Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany), setting out why intervention...
Merit Medical has announced that is has completed enrolment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomised, controlled, multicentre study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty...
AngioDynamics has announced the completion of enrolment and final treatment in its pivotal study of the NanoKnife system for ablation of prostate tissue in an intermediate-risk patient population (PRESERVE). The PRESERVE study was initiated by AngioDynamics. in partnership with...
Alucent Biomedical has announced that the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a US clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
AlucentNVS combines an intravascular device with a photochemical...
Authors from King’s College Hospital (London, UK) have recently published a letter in Clinical Radiology detailing their centre’s experience after 25 years of day-case interventional radiology (IR) services. The King’s experience, according to the title of the response letter,...
Petra Svarc (Rigshospitalet, Copenhagen, Denmark) presented during the scientific paper session at the European Conference on Embolotherapy (ET; 21–24 June, Valencia, Spain). She imparted on the audience the results of hers and colleagues’ double-blinded randomised controlled trial (RCT) of...
Interventional News’ most popular stories from July included point of view pieces from interventional radiologists on fallopian tube recanalisation and interventions for postpartum haemorrhage, respectively; news of an editorial from The Cardiovascular Interventional Radiological Society of Europe (CIRSE) which...
IceCure Medical has announced in a press release that Health Canada, the Canadian government's regulatory agency, has approved IceCure's ProSense system, disposable cryoprobes, and introducers as cryosurgical tools for indications including:
Tumours—ablation of benign and malignant tumours of the...
Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company's Human Acellular Vessel (HAV) in vascular trauma repair.
A press release details...
Bracco Imaging has announced the publication of the PROMISE trial in Radiology. The PROMISE study was a prospective, multinational, crossover (within-patient), double-blind comparison of the safety and efficacy of 0.05 mmol/kg gadopiclenol (Vueway) with 0.1 mmol/kg gadobutrol (Gadavist) in adult...
MediView announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its XR90 augmented reality-based surgical visualisation and navigation platform. XR90 is intended to be used adjunctively for minimally invasive ultrasound and computed tomography...
Francis Medical, Inc, a privately held medical device company developing an innovative and proprietary water vapour ablation therapy for the treatment of prostate, kidney, and bladder cancer, has announced the first patient has been treated in the company's VAPOR...
The Society of Interventional Radiology (SIR) has published a position statement offering recommendations on the management of chronic iliofemoral venous obstruction with endovascular placement of metallic stents. The statement, published online in the Journal of Vascular and Interventional Radiology, is a...
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since US Food and Drug Administration (FDA) approval of the system was granted. This marks the official start...
The European Institute for Biomedical Imaging Research (EIBIR) has today announced the appointment of Regina Beets-Tan as its new scientific director. Beets-Tan, EIBIR states, will contribute to further enhancing the organisation support of European biomedical imaging research and...
In June 2023, the Cardiovascular Interventional Radiological Society of Europe (CIRSE) published an editorial in Cardiovascular Interventional Radiology (CVIR). Written on behalf of CIRSE’s Endovascular Subcommittee, the authors “advocate that the benefits of paclitaxel-coated device used in the femoropopliteal...
This advertorial is sponsored by Terumo Interventional Systems
LifePearl™ microspheres (Terumo) are polyethylene glycol (PEG) embolization microspheres that can be loaded with chemotherapeutic drugs including doxorubicin, irinotecan, idarubicin and epirubicin¹. Philippe Pereira (SLK-Kliniken GmbH, Heilbronn, Germany) speaks to Interventional News...
Biotronik has announced one-year subgroup results from the investigator-initiated BIOPACT randomised controlled trial (RCT), which were presented by principal investigator Koen Deloose (AZ Sint-Blasius, Dendermonde, Belgium) at this year’s Leipzig Interventional Course (LINC 2023, 6–9 June, Leipzig, Germany).
The randomised...
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclitaxel coated devices for the peripheral arterial disease (PAD) marks an important chapter in a long-running story.
December 2018
Meta-analysis finds a higher risk...
Following yesterday's news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD), Boston Scientific has announced its position on the update. The company's full...
Verve Medical has received approval from the US Food and Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL-Denervation) pivotal investigational device exemption (IDE) trial for the treatment of uncontrolled hypertension to lower blood pressure.
The...
Cagent Vascular has announced the results of its below-the-knee (BTK) RECOIL study. This core lab-adjudicated Recoil analysis— the first of its kind, according to the company— evaluated vessel recoil in lesions treated with Serranator verses plain balloon angioplasty.
The study...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on...
Boston Scientific has received US Food and Drug Administration (FDA) 510(k) clearance for its Embold soft and packing coils, the company has announced in a press release. The coils are designed for use in a variety of embolization procedures.
These...
Each woman is unique, and a one-size-fits-all approach is not appropriate for addressing what can be extremely complex reproductive health issues.
Natural Procreative (NaPro) technology, is a groundbreaking medical approach that focuses on understanding and treating the underlying causes of...
Canon Medical has announced the commercial availability of its two latest ultrasound systems, Aplio flex and Aplio go, in Europe. With the growing challenges faced by medical staff, including high workload and work-related musculoskeletal disorders, Canon Medical recognises the...
Interventional News’ most popular stories from June included a letter from the joint editor-in-chief on the current state of interventional radiology (IR) practice and where it needs to be; an interview with a New Zealand interventional radiologist on Australasian...
Why is clot removal crucial for patients suffering from DVT? What are the major benefits of a lytic-free thrombectomy? Watch Michael Lichtenberg (Arnsberg, Germany) present the outcomes of the Arnsberg ClotTriever Study which confirms the safety and efficacy of...
A French group of interventional radiologists and urologists has recently published the results of its randomised, multicentre, open-label, phase 3 superiority trial of prostate artery embolization (PAE) versus medical therapy (PARTEM) in The Lancet. The group, of whom Marc...
The Cardiovascular Interventional Radiological Society of Europe (CIRSE) 2020 Standards of Practice document for gynaecological and obstetric haemorrhage are among the most comprehensive guidelines in interventional radiology (IR) for obstetric interventions. The guidelines cover the use of IR for...
Terumo Aortic have today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for commercial sale in Japan for the treatment of patients with complex...
UK's National Institute for Health and Care Excellence (NICE) announced on 28 June that it recommends the use of radiofrequency ablation (RFA) for the treatment of osteoarthritic knee pain.
Osteoarthritis is the most common form of arthritis, and for patients...
Microvention, a wholly owned subsidiary of Terumo, has announced that the Eric retrieval device is now commercially available in the USA for ischaemic stroke treatment, having received 510(k) clearance from the US Food and Drug Administration (FDA) on 31...
As announced at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA), the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter product line is now available with even more options. Interventionists...
The US Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).
The clinical study will assess the safety and effectiveness of the ZFEN+...
Following the publication of an animal study examining the performance of embolization coils in arteries in the Journal of Vascular and Interventional Radiology (JVIR) in 2019, a second, similar study, published in the May 2023 issue of JVIR, examined...
Surmodics has announced the receipt of US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).
A company press release notes that the SurVeil DCB may now be marketed and sold in the USA to physicians for...
On 5 June, the Society of Interventional Radiology (SIR) held a briefing in Washington DC, USA, of which the focus was benign prostate hyperplasia (BPH). The briefing took place in conjunction with the US Congressional Men’s Health Caucus. Shivank...
Shang Loh is chief of vascular surgery and endovascular therapy at Penn Presbyterian Medical Center and professor of clinical surgery at the University of Pennsylvania (both Philadelphia, USA). Ahead of the Embolization for Vascular Surgeons: Techniques, Tips and Tricks...
The 50th patient has been treated using the Epione robot from Quantum Surgical by the team of Laurent Milot, deputy chief vascular and interventional radiology at the Hospices Civils de Lyon (HCL; Lyon, France), highlighting a successful collaboration only...
Merit Medical Systems has announced that it has completed the acquisition of a portfolio of dialysis catheter products and the BioSentry biopsy tract sealant system.
“We are selectively investing to expand our product portfolio in key strategic markets that leverage...
Interventional radiology (IR) is unique amongst procedural disciplines because its ‘parent specialty’ is a diagnostic discipline that has no infrastructure for clinical practice. Charles Dotter, who performed the first angioplasty on 16th January 1964, recognised the risks inherent in...
NOTE: This video is ONLY available to watch in selected countries and geographies
The combined use of a drug-eluting device and a vascular scaffold “seems to be, in the longer run, the perfect solution for complex lesion treatment”. This...
The recent haemodialysis access guideline update from the UK Kidney Association (UKKA), which was published in the run-up to the 2023 UK Kidney Week conference (UKKW; 5–7 June, Newport, UK), marks a considerable shift in how the organisation recommends...
A multicentre study presented at the recent European Stroke Organisation Conference (ESOC; 24–26 May, Munich, Germany) has found that vision recovery and an increased likelihood of early neurological improvement are among the potential benefits endovascular therapy (EVT) can offer...
Surmodics announced in a press release that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low profile) thrombectomy system.
Introduced in 2021, the Pounce thrombectomy system is intended for the non-surgical removal...
Terumo Aortic announced in a press release the launch of the company’s global post-approval study (PAS) known as EXTEND for Thoraflex Hybrid, the only frozen elephant trunk (FET) device approved by the US Food and Drug Administration (FDA) for...
Interventional radiologist Nick Brown is clinical director of the radiology service at The Wesley Hospital (Auchenflower, New Zealand) and associate professor at the University of Queensland (Brisbane, Australia). He sat down with Interventional News at the European Conference on...
Presenting first-time data from large multicentre European studies at this year's Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Arne Schwindt (St Franziskus Hospital Münster, Münster, Germany) and Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany) delivered results that...
Delivering first-release data, Scott O Trerotola (University of Pennsylvania, Philadelphia, USA) conveyed the “consistent results” in a real-world environment for the Lutonix arteriovenous (AV) post-approval study (PAS) for drug-coated balloon (DCB)-AV on the afternoon of the second day at...
The 'Connect the world: Japan' session at this year’s Leipzig Interventional Course (LINC 2023, 6–9 June, Leipzig, Germany)—in collaboration with the Japanese Endovascular Treatment Conference (JET)—sparked discussion surrounding the latest data in femoropopliteal interventions. Giving platform to multiple...
Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour System to treat patients with complex peripheral arterial disease (PAD).
Patients with long blockages of the superficial femoral artery...
In a second compassionate use case, interventional vascular surgeon Stefan Stalhoff of Klinikum Hochsauerland (Arnsberg, Germany) used VeinWay's Traversa for venous recanalisation to save a patient's arm, with supervision by VeinWay scientific advisory board member Michael Lichtenberg. The patient had...
Bentley announced at the annual Leipzig Interventional Course (LINC; 6–9 June, Leipzig Germany) that it has reached an important milestone: having sold the 300,000th BeGraft. This milestone was celebrated at the Bentley booth at LINC.
After launching the first BeGraft...
Inari Medical today announced the launch of two new purpose-built products, the RevCore thrombectomy catheter, and the Triever16 Curve catheter.
According to a company press release, RevCore is the first mechanical thrombectomy device designed to address venous in-stent thrombosis, an...
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design and conduct of clinical trials.
In a statement, the regulator said that the updates are intended...
Teleflex has announced in a press release that the Arrow EZ-IO Needle is the first and only intraosseous (IO) needle to receive 510(k) clearance from the US Food and Drug Administration (FDA) for magnetic resonance (MR) conditional labelling. The EZ-IO...
Argon Medical has announced the launch of the SuperCore Advantage semi-automatic biopsy instrument as the newest addition to its soft tissue biopsy product portfolio in the USA.
The SuperCore Advantage is a disposable soft tissue biopsy instrument that provides a...
Profound Medical has announced in a press release that, with sponsorship and support from multiple physician specialty societies, the American Medical Association (AMA) has established three new Current Procedural Terminology (CPT) category 1 codes for magnetic resonance imaging (MRI)-monitored...
Shape Memory Medical has announced the publication of results from the company’s prospective, open-label, single-arm, safety study of the IMPEDE embolization plug in peripheral vascular embolization. The study was published this month in the peer-reviewed journal, Vascular, ahead of...
Biotronik today announced the limited release of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at this year's Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany).
As indicated per Instructions for...
Interventional News’ most popular stories from May included a forecast of where embolization is headed from a Global Embolization Oncology Symposium (GEST, 18–21 May, New York City, USA) presenter, the announcement of Bentley's first US product launch and Quantum...
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president and general manager of consumer robotics, and will lead technology development across industries including robotics,...
IceCure Medical has announced that ProSense was recently installed and inaugurated at Kovai Medical Center and Hospital (KMCH) in Coimbatore, India. This development, to the company's knowledge, constitutes the first instance of cryoablation for breast cancer treatment being offered...
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most advanced and powerful arterial thrombectomy system on the market.
Lightning Bolt 7 introduces a new method...
Adept Medical has announced the launch of the Head Immobiliser—a radiolucent support for a range of interventional radiology (IR) and neuroradiology procedures. Now commercially available, the positioning device can help mitigate the costs of retakes, from reducing the amount...
ABK Biomedical has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to commence a multicentre pivotal clinical study in the USA for its Eye90 microspheres yttrium-90 (Y90) radioembolization therapy.
The pivotal clinical...
Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan Endovascular Treatment (JET) Conference (26–28 May, Tokyo, Japan). The objective of this study was to assess the safety and efficacy of the...
Cora Therapeutics has announced the presentation of the results of a clinical trial at the Canadian Association of Interventional Radiologists (CAIR) annual meeting (25–27 May, Quebec City, Canada), assessing the efficacy of its proprietary antioxidant complex in safeguarding DNA...
On 24 May, the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) approval for Concept Medical's MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) for treatment of the superficial femoral artery (SFA).
This marks the fourth...
Govindarajan Narayanan, chief of interventional oncology at Miami Cancer Institute and a vascular interventional radiologist with Miami Cardiac & Vascular Institute (both Miami, USA), successfully treated the first patient in the USA with a liver tumour using Quantum Surgical’s...
A new study using data from millions of patients hospitalised across the USA has determined whether population density and associated urban versus suburban versus rural environments predispose patients with peripheral vascular disease for chronic poor blood flow in their...
Data from a cohort of one million patients with chronic limb-threatening ischaemia (CLTI) were recently presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA). Using data from Medicare,...
Steven Abramowitz (Washington DC, USA) explains the significance of the CLOUT registry—the only registry capturing data on mechanical thrombectomy in deep venous thrombosis (DVT). CLOUT confirms excellent safety results and effectiveness of the ClotTriever system in real-world DVT patients....
Six-month outcomes from FLASH registry have shown that patients with pulmonary embolism who were treated with mechanical thrombectomy showed significant improvement in symptoms, quality of life and cardiac functions.
The findings were presented as late-breaking clinical research at the Society...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
During a recent webinar hosted by Inari Medical, a multidisciplinary group of physicians focused in on how to select eligible patients for the endovascular treatment of...
A new analysis of chronic limb-threatening ischaemia (CLTI) treatment outcomes was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA), a press release reports.
Following the initial...
Discussing the role of artificial intelligence (AI) in improving outcomes within research and practice development, Hamid Mojibian (Yale School of Medicine, New Haven, USA) explicated the ways in which AI is changing interventional radiology (IR) at the 2023 Global...
Speaking in the Vanguard session on the first day of the 2023 Global Embolization Oncology Symposium (GEST, 18–21 May, New York City, USA) yesterday, Lindsay Machan (University of British Columbia, Vancouver, Canada) gave a comprehensive outlook on the next...
Setting the audiences sights on the horizon at the 2023 Global Embolization Oncology Symposium (GEST, 18–21 May, New York City, USA) yesterday, Daniel Sze (Stanford University, Stanford, USA), editor in chief of the Journal of Vascular and Interventional Radiology,...
Bentley has announced the US launch of its BeBack crossing catheter, which is designed for the treatment of heavily calcified lesions. This is the company's first product to be launched in the USA.
A press release notes that, after the...
The use of an image-guidance system that overlays angiographic images on live fluoroscopic images has been shown to reduce the amount of contrast used during percutaneous coronary intervention (PCI), trial data shared at EuroPCR 2023 (16–19 May, Paris, France)...
A recent proposal has called for “whole-person, multidisciplinary interventions” after an interrogation of the interplay between lower extremity peripheral arterial disease (PAD) and mental health impacts. Published in the Journal of The American College of Cardiology, researchers have put...
Varian, a Siemens Healthineers company, is introducing the Isolis cryoprobe, a single-use, disposable device designed for use with CryoCare systems that seeks to improve procedural efficiency and precision for cryoablation.
The new Isolis cryoprobe offers the interventional radiologist greater...
Akura Medical announced today it has initiated its first-in-human clinical study of the Akura mechanical thrombectomy platform. A press release notes that the Akura platform is a low-profile solution designed to easily access and efficiently remove large-volume, mixed-morphology clots,...
Guerbet has announced in a press release that based on the most recent scientific and clinical evidence, the American College of Radiology (ACR) Committee on Drugs and Contrast Media has classified Elucirem (gadopiclenol) as a group II agent. This...
Stereotactic body radiotherapy (SBRT) is being used increasingly in early-stage lung cancer. Between 2012 and 2018, the proportion of otherwise healthy patients treated with SBRT increased from 15 to 26%.
A study at the Yale University School of Medicine (New...
Microbot Medical, the developer of the Liberty robotic system, the first single-use endovascular robotic system, has received the histopathology report from the research laboratory that performed the animal study for the Liberty robotic system in October 2022. The company...
Judges of the CX 2023 Dragon’s Den-style contest—the finale of the Charing Cross (CX) Symposium (25–27 April, London, UK) Innovation Showcase programme—described the field of entrants to this year’s edition of the competition as the strongest line-up in its...
Several of Interventional News’ most read stories from April covered the topic of interventional oncology (IO)—its interrelation with immuno-oncology, a robot-assisted lung metastases treatment, and articles featuring analysis of current guidelines for cancers in the liver and kidneys. The...
Xeltis has presented “highly-encouraging” six-month data from its first-in-human (FIH) aXess vascular graft trial at the 13th Congress of the Vascular Access Society (VAS; 27–29 April, Porto, Portugal).
A press release outlines that six-month data from the FIH trial found...
The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA).
This study evaluates SELUTION SLR in the treatment of occlusive disease of the superficial femoral...
Teleflex has announced new research findings reinforcing the long-term durability of prostatic urethral lift (PUL) with the UroLift system and lower complication rates compared to other minimally invasive procedures for men with enlarged prostate, also called benign prostatic hyperplasia...
Vivasure Medical has announced it has enrolled the first patients in the company’s PerQseal PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system. The first patients were enrolled...
Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study's findings showed that there was no significant difference in aneurysm-related outcomes between patients randomised to...
The US Food and Drug Administration (FDA) has granted the third investigational device exemption (IDE) approval for Concept Medical's MagicTouch sirolimus-coated balloon (SCB). Along with this latest IDE approval for the treatment of small vessels, Concept Medical received two...
Philips has announced the launch of Zenition 10, a new addition to the company’s Zenition mobile C-arm series. Based on Philips’ flat panel detector technology, Zenition 10 helps to expand patient access to routine surgical care and minimally invasive...
The American Urological Association (AUA), in partnership with the Society of Urologic Oncology (SUO), released the 2023 clinical practice guidelines for the diagnosis and management of non-metastatic upper tract urothelial carcinoma (UTUC). Of key importance is the fact that...
This advertorial is sponsored by Boston Scientific.
During a recent satellite symposium, which took place at the 2022 Cardiovascular Interventional Radiological Society of Europe (CIRSE) annual meeting (10–14 September, Barcelona, Spain), experts emphasised the clinical value of drug-eluting technologies (DET)...
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to their multidisciplinary team meetings from the first-time presentation of BASIL-2 led chief investigator Andrew Bradbury...
Penumbra recently announced the launch of the latest addition to its RED family of catheter devices for mechanical thrombectomy, the RED 43 reperfusion catheter.
According to the company, this device is intended to take distal aspiration “to the next level”...
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to their multidisciplinary team meetings from the first-time presentation of BASIL-2 led chief investigator Andrew Bradbury...
Bentley has bought its main supplier, the Switzerland-based Qmedics, Bentley has recently announced in a press release. It also announced its plan of initial public offering (IPO), which is planned for autumn/winter 2023/2024, depending on market conditions.
Qmedics manufactures approximately...
Vestibular schwannomas related to neurofibromatosis type 2 (NF2) are difficult to manage and are sometimes treated with a noninvasive option—stereotactic radiosurgery. A retrospective study conducted by an international, multicentre team and reported in Neurosurgery found that stereotactic radiosurgery is effective for...
Dimitrios Filippiadis (National and Kapodistrian University of Athens , Athens, Greece) was the final speaker to take to the podium at the European Conference on Interventional Oncology’s (ECIO; 16–19 April, Stockholm, Sweden) advanced musculoskeletal (MSK) session. His presentation drew...
IceCure, developer of the minimally-invasive cryoablation ProSense System which has shown promise in the treatment of renal masses, has announced that it has been used in a single-site study conducted at the Sorbonne University Department of Interventional Radiology and...
Surmodics has announced enrolment of the first patient in PROWL, the Pounce thrombectomy system retrospective registry. PROWL is an open-label, retrospective, multicentre US registry of the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral...
Day two of the European Conference on Interventional Oncology (ECIO; 16–19 April, Stockholm, Sweden) opened with a session dedicated to posing and responding to the most burning questions regarding colorectal cancer (CRC) metastases. Alessandro Vitale (University of Padua, Padua,...
Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were the first physicians to use the company’s Sublime radial access microcatheter.
The Sublime microcatheter is in...
GE HealthCare is further advancing its precision care strategy with CT-Navigation, which offers clinicians detailed, real-time, 3D computed tomography (CT) images for stereotactic needle guidance across an array of care areas, including interventional and oncological procedures, as well as...
BlackSwan Vascular, a privately held company that is developing innovative therapies in endovascular embolization, is has announced it has received US Food and Drug Administration (FDA) Premarket Approval (PMA) of its Lava Liquid Embolic System (Lava LES) for treatment...
Two of the sessions from day one of the 2023 European Conference on Interventional Oncology (ECIO; 16–19 April, Stockholm, Sweden) drew delegates’ focus to what the evidence in interventional oncology (IO) and immuno-oncology is indicating in 2023. Specifically, hepatocellular...
Quantum Surgical announces the ongoing clinical trial for the treatment of lung metastases assisted by the Epione robot.
The study is coordinated by Thierry de Baere (Gustave Roussy, Villejuif, France) and will evaluate the clinical performance and safety of...
Christos Georgiades (Johns Hopkins University, Baltimore, USA), delves into the various national society guidelines for treating renal cell carcinoma (RCC), what the ‘gold standard’ of treatment is currently considered to be, and what he believes is the route to...
Adept Medical has launched the Adducted Arm Scoop—an improved solution for supporting the adducted arms of supine patients during image-guided procedures.
Adept’s new, “extremely durable” Adducted Arm Scoops are purpose-designed, providing security and comfort on narrow imaging tables, as per...
Fabian M Laage Gaupp is assistant professor of radiology and biomedical imaging at Yale School of Medicine (New Haven, USA) and a recipient of the Yale Institute for Global Health’s winter 2023 Spark Awards. This monetary prize will see...
Recent advances in immuno-oncology are transforming the practice of medical oncology. Currently, antibodies directed against negative regulators of T-cell function, the so-called checkpoint inhibitors, oncolytic virus, and engineered cell therapies such as chimeric antigen receptor (CAR)-T products have received...
At the Society of Interventional Oncology (SIO) annual scientific meeting (19–23 January, Washington DC, USA), Sean Tutton (University of California San Diego Health, San Diego, USA) presented evidence on treatment for musculoskeletal (MSK) metastases, while urging those involved in...
Nima Kokabi (Emory Healthcare, Atlanta, USA) addressed the “uncomfortable truth” of healthcare disparities in the USA specifically within interventional radiology (IR) in a presentation at the Society of Interventional Radiology 2023 annual scientific meeting (4–9 March, Phoenix, USA). He...
A session at the recent Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA) put the focus on the landscape of interventional radiology (IR) in Latin America. Members from the affiliate societies Sociedad Iberoamericana de Intervencionismo...
“My interest in understanding and tackling health disparities has grown while here in Alabama as I have become increasingly aware of the imbalance of opportunities for patients in this state.” Theresa Caridi is an interventional radiologist based at the...
Interventional News 90 Highlights:
Letter from joint editor-in-chief Andreas Adam
How dogs with seizures inspired a novel neuro-oncology trial
Profile: Theresa Caridi
Progress travelled on the Road2IR in sub-Saharan Africa
Advertorial: “Intuitive” new biopsy system delivers on reducing “inherent”...
Interventional News 90 Highlights:
Letter from joint editor-in-chief Andreas Adam
How dogs with seizures inspired a novel neuro-oncology trial
Profile: Theresa Caridi
Progress travelled on the Road2IR in sub-Saharan Africa
Advertorial: “Intuitive” new biopsy system delivers on reducing “inherent”...
This advertorial is sponsored by Merit Medical.
Consultant interventional radiologist Damian Mullan (The Christie NHS Foundation Trust, Manchester, UK) speaks to Interventional News about his experiences with Merit Medical’s Temno Elite™ biopsy system at his hospital, the largest single-site cancer...
Justin Guan is an interventional radiologist practising at the Cleveland Clinic (Cleveland, USA), who is also involved in the Society of Interventional Radiology’s (SIR) International Division. He and other members of the division are currently conducting a survey of...
HistoSonics has announced the first kidney patient has been treated using its histotripsy platform. The procedure was performed at the Leeds Teaching Hospitals NHS Trust (Leeds, UK) by Tze Min Wah, senior consultant radiologist and clinical lead for interventional...
AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its pulsatile intravascular lithotripsy (PIVL) therapy, has announced that it closed an additional US$8.8 million in new financing, bringing its Series B...
Interventional News’ most popular stories from March included those covering new embolization and radiofrequency ablation data presented at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA); news of the launches of a new peripheral...
A new investigation into the association between end-stage renal disease (ESRD) and major adverse limb events (MALEs) has found that not only is it strong, but ESRD is particularly associated with below-knee amputation. The details of the study were...
Results from the PROMISE II pivotal trial investigating transcatheter arterialisation of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischemia (CLTI) patients were today published in the New England Journal of Medicine (NEJM).
The publication confirmed...
Researchers found that a minimally invasive procedure combined with epidural steroid injection treatment led to superior pain reduction and disability improvement over one year in patients with sciatica. The results of the study were published in Radiology, a journal...
IceCure Medical, developer of minimally invasive cryoablation technology, the ProSense System (marketed under the brand name IceSense3 in China), that destroys tumours by freezing as an alternative to surgical tumour removal, has announced the National Medical Products Administration (NMPA) of...
Data and discussion on revascularisation treatment strategies for patients with chronic limb-threatening ischaemia (CLTI) will take centre stage at the CX 2023 Consensus update, with results from the BASIL-2 (Bypass versus angioplasty in severe ischaemia of the leg-2) randomised...
Delcath Systems has announced in a company press release that the US Food and Drug Administration (FDA) has accepted its (Delcath's) new drug application resubmission for Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system) seeking approval for the treatment...
Getinge's iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), which...
A range of experts, including Koen Deloose (Dendermonde, Belgium), Thomas Zeller (Bad Krozingen, Germany), Marianne Brodmann (Graz, Austria) and Antonio Micari (Messina, Italy), talk to Vascular News about how the latest data supporting the cost-effectiveness of the IN.PACT Admiral drug-coated balloon...
SurgVision, a company developing pioneering solutions for fluorescence-guided surgical and interventional oncology, part of the Bracco Group, has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Explorer Air II for...
EDAP TMS, a global leader in robotic energy-based therapies, has announced a recent presentation of positive results from a large, multicentre, noninferiority study comparing Focal One high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 38th annual congress...
Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter (Biotronik) compared to the IN.PACT Admiral...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of Health and Social Care (DHSC)—to help bring innovative new medicines and medical technologies to UK...
Merit Medical has announced the expansion of itsSwiftNinja steerable microcatheter product line. New sizes include a low-profile 2.4Fr distal diameter option in 125-cm and new longer 150-cm lengths.
The 180-degree articulating microcatheter is designed to provide access to challenging peripheral...
The Society of Vascular and Interventional Neurology (SVIN) has released its first global analysis of access to mechanical thrombectomy for the treatment of large vessel occlusion (LVO) stroke. Findings from MT-GLASS—a study conducted as part of the SVIN Mission...
When receiving treatment for abdominal aortic aneurysm (AAA), female patients have a higher risk for kidney damage after endovascular repair, a Michigan Medicine study finds.
Researchers from Michigan Medicine designed an algorithm that can be used prior to endovascular AAA...
Shockwave Medical today announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food and Drug Administration (FDA).
A press release details that the Shockwave L6 catheter is purpose-built to...
The final results of the RAVI prospective registry study demonstrated the safety and efficacy of radial access in visceral interventions in standard embolization procedures for uterine fibroids, benign prostatic hyperplasia, and hypervascular tumours. The findings of the Terumo Medical-sponsored...
A new trial of endovascular ultrasound-based renal denervation technology has found that it reduced blood pressure in hypertensive patients at two months. The RADIANCE II study, published in The Journal of the American Medical Association (JAMA), was carried out...
Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection...
NeoDynamics, a medical device company dedicated to advancing the diagnosis and care of cancer, recently announced that the company has been granted a Chinese patent for the needle design employed in the NeoNavia FlexiPulse probe.
The front-loaded, open-tip sampling needle...
Michel Reijnen (Arnhem, The Netherlands) presents the results of a study that sought to assess the potential cost-effectiveness of a urea-based drug-coated balloon (DCB; IN.PACT Admiral, Medtronic) as standard of care treatment for those with chronic limb threatening ischaemia...
New interventional oncology data from Galvanize demonstrate positive preclinical and early clinical study results using the Aliya pulsed electric field (PEF) system.
The Aliya PEF system, which has US Food and Drug Administration (FDA) clearance for soft tissue ablation, is...
Argon Medical, a leading provider of device solutions for interventional radiology (IR), vascular surgery, interventional cardiology, and oncology, introduces the Traveler portal vein access series as the newest addition to its portal vein access product portfolio. The product line...
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).
Producers of medical devices will have until 31 December 2027 for higher risk...
Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischaemia and a 15% reduction in major adverse limb and cardiovascular...
Lead researchers Clifford Weiss and Daniel Giraldo Herrera (Johns Hopkins University School of Medicine, Baltimore, USA) presented their recent bariatric arterial embolization (BAE) study at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA). Their...
Robert A Lookstein, who is executive vice chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital (New York, USA) today presented the results of a subanalysis of Thrombolex’s National Heart, Lung and...
Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the...
Viz.ai has announced it will use its Viz Recruit platform to optimise patient enrolment for the National Institutes of Health (NIH)-funded Pulmonary embolism—thrombus removal with catheter-directed thrombolysis (PE-TRACT) clinical trial.
The company claims that PE-TRACT will be the most rigorous...
In a first-in-human, compassionate use case approved by the US Food and Drug Administration (FDA), University of Michigan Health (Ann Arbor, USA) interventional radiologists David M Williams and Minhaj S Khaja successfully used VeinWay's Traversa for venous recanalisation to...
Interventional News’ most popular stories for the month of February included news from the Pan Arab Interventional Radiology Society annual meeting (PAIRS; 11–14 February, Dubai, UAE), along with other global meetings from the first couple of months of 2023;...
The keynote lecture on day one of the Pan Arab Interventional Radiology Society annual meeting (PAIRS; 11–14 February, Dubai, UAE) advocated a simultaneously global and local approach when it comes to conducting research in interventional radiology (IR), and when...
ReCor Medical and its parent company, Otsuka Medical Devices, recently announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise ultrasound...
Genicular nerve radiofrequency ablation is a minimally invasive treatment for knee pain due to osteoarthritis of the knee, and can significantly reduce pain, especially for adults who are 50 and older, according to new research to be presented the...
A minimally invasive treatment that injects allograft disc tissue into the spine to relieve pain associated with degenerative disc disease provides significant improvement in pain and function over a sustained period, according to new research to be presented at...
Prostate artery embolization (PAE) provides long-term effectiveness in treating urinary symptoms from an enlarged prostate gland, according to new research to be presented at the Society of Interventional Radiology (SIR) annual scientific meeting (4–9 March, Phoenix, USA).
In the largest...
The Journal of Vascular and Interventional Radiology (JVIR) published a paper in January 2023 examining the potential barrier that the name of the interventional radiology (IR) specialty poses to the US public’s understanding of the role of interventional radiologists....
Microbot Medical has announced that Japan is the most recent global jurisdiction to recognise the unique interface design of the Liberty robotic system’s remote controller. The design patent, which was issued by the Japan Patent Office (JPO), complements similar...
Sarah White (Medical College of Wisconsin, Milwaukee, USA) opened the liver interventional oncology (IO) session at the Pan Arab Interventional Radiology Society (PAIRS) annual meeting (11–14 February, Dubai, UAE) with a presentation that set out what she believes to...
Few adverse events are connected to the use of inferior vena cava (IVC) filters to help prevent deep vein blood clots from developing into pulmonary embolisms (PE), according to the findings of the Predicting the safety and effectiveness of...
David Gillespie (Boston, USA) talks to Interventional News about the PRESERVE study—established by the Society for Vascular Surgery and Society of Interventional Radiology—which is the largest prospective study to investigate real-world outcomes with contemporary use of inferior vena cava...
Humacyte, a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced the publication of “Six-year outcomes of a phase two study of human-tissue engineered blood vessels...
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Robert Shahverdyan (Hamburg, Germany), Matteo Tozzi (Varese, Italy), Alexandros Mallios (Paris, France), Ounali Jaffer (London, UK) and Narayan Karunanithy (London, UK) each give their take on...
Shape Memory Medical has announced the first patient treated in Germany as part of the EMBO postmarket surveillance registry (EMBO-PMS), the company’s prospective, multicentre registry study of its Impede and Impede-FX embolization plugs when used for peripheral vascular embolization.
The...
The publication of a consensus statement from the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) is among the final steps in the evaluation of renal denervation as a device-based...
Compared to other races, African American patients are more likely to experience premature arteriovenous (AV) graft failure in the treatment of advanced kidney failure, according to a study published in Radiology, a journal of the Radiological Society of North...
Mechanical thrombectomy appears to be a safe and technically feasible treatment option for ischaemic strokes caused by primary isolated anterior cerebral artery (ACA) occlusions in more distal locations. The procedure—which is more traditionally used in large vessel occlusions (LVOs)...
Xeltis has raised €32 million in a Series D2 equity fundraise, backed by a syndicate of current and new investors, which the company says will enable it to progress its clinical programmes into pivotal trials.
Investors include Grand Pharma, DaVita...
Rana Tarek M Khafagy is a consultant interventional radiologist based at Ain Shams University Hospital (Cairo, Egypt). In her capacity as head of the Pan Arab Interventional Radiology Society (PAIRS) residents, fellows and students (RFS) section committee, she sat...
This advertorial is sponsored by Argon Medical.
Danial Jilani is an interventional radiologist based at Northwestern Medicine Palos Hospital (Chicago, USA), who uses the SKATER™ drainage catheter (Argon Medical) as his “go-to” catheter for a range of both “bread and...
Renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.
These are among the messages of a new consensus statement published in EuroIntervention following a review...
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Iliac side branch devices (ISBs) are “gamechangers in infrarenal therapy of abdominal aortic aneurysms (AAAs),” Mario Lescan (Tübingen, Germany) tells Vascular News. Lescan states that ISBs “allow...
Delcath Systems has announced it has submitted a new drug application (NDA) resubmission to the US Food and Drug Administration (FDA) for the Hepzato Kit (melphalan hydrochloride for injection/hepatic delivery system, or melphalan/HDS) seeking approval for the treatment of...
Guerbet has shared in a press release that it has commercially launched Elucirem (gadopiclenol) and the first patient has received a dosing. This is following US Food and Drug Administration (FDA) approval in 2022. The first dosing took place...
Biotronik has announced the US Food and Drug Administration (FDA) 510(k) clearance and CE mark of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter.
The company notes in a press release that Oscar is intended for percutaneous...
In a recent study of patients with intermittent claudication (IC) caused by isolated superficial femoral artery (SFA) lesions, researchers found that primary stenting conferred benefits in health-related quality of life (HRQoL) at 36 months from treatment compared with best...
“When I relocated to Lebanon, I was the only person with practical experience and expertise in EVAR in the Middle East.” It was thus that Aghiad Al-Kutoubi became the first in the Arab world to perform this procedure,...
The Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon catheter (DCB) has received investigational device exemption (IDE) for the treatment of below-the-knee (BTK) atherosclerotic lesions in peripheral arterial disease (PAD). Concept Medical received its first IDE approval for the...
On day two of the Pan Arab Interventional Radiology Society annual meeting (PAIRS; 11–14 February, Dubai, UAE), Riad Salem (Northwestern University, Chicago, USA) took to the podium to give insight into a new frontier in interventional oncology (IO)—yttrium 90...
Clinical Laserthermia Systems Americas (CLS) and HALO Precision Diagnostics (HALO) have announced a letter of intent to evaluate the safety and short-term efficacy of CLS’s Tranberg thermal therapy system for treating low- to medium-risk prostate cancer patients with focal...
Abbott and Cardiovascular Systems (CSI) have announced a definitive agreement for Abbott to acquire CSI. Under terms of the agreement, CSI stockholders will receive US$20 per common share at a total expected equity value of approximately US$890 million.
CSI is...
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In this Vascular News roundtable, Andrew Holden (moderator; Auckland, New Zealand) is joined by Alexandros Mallios (Paris, France), Kate Steiner (Stevenage, UK) and Tobias Steinke (Düsseldorf, Germany) who...
Northeast Scientific announced this week it has received US Food and Drug Administration (FDA) 510(k) clearance for reprocessing the intravascular ultrasound (IVUS) Eagle Eye Platinum RX digital catheter (Philips).
CEO and founder, Craig Allmendinger shared his thoughts on the impact...
In the past two decades, there has been a shift in varicose vein management from conventional surgical treatments to outpatient interventional procedures. Depending on the type and site of the affected vein, patients now have many other treatment options—namely...
Interventional News’ most popular stories in the opening month of 2023 included news of first enrolments in clinical studies of peripheral arterial disease (PAD) and deep vein thrombosis (DVT), respectively; key takeaways from a conference myth-busting session centring on...
Researchers at Moffitt Cancer Center (Tampa, USA) are investigating new treatment approaches for the primary lung neuroendocrine tumour patient population. In a new article published in the International Journal of Radiation Oncology, Biology and Physics, a team of physicians, led...
Guerbet has announced the first production batch has been manufactured and released for Elucirem (gadopiclenol) injection following US Food and Drug Administration (FDA) approval in September 2022, after priority review. The highly stable macrocyclic gadolinium-based contrast agent (GBCA) has...
A number of speakers took to the stage at the International Symposium on Endovascular Therapies (ISET; 16–19 January 2023, Miami Beach, USA) to debate the ‘ambulatory shift’ that is currently taking place in the interventional space.
Aaron Mauck (Advisory Board,...
This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in both Europe and the USA following the company’s acquisition of Upstream Peripheral Medical Technologies’ GoBack...
Mina S Makary, assistant professor at the Division of Vascular and Interventional Radiology/Department of Radiology at the Ohio State University Wexner Medical Center (Columbus, USA) and collaborator Warren A Campbell IV from Ohio State University’s medical scientist training programme...
During the Society of Interventional Oncology (SIO) 2023 annual scientific meeting in Washington DC, USA, a panel of speakers delivered presentations on why patient-centred care is important, and how to provide it most effectively. The session comprised perspectives beyond...
Interventional News 89 Highlights:
Interview: Specialist clinic brings IVC filter innovation into focus
RCR president advocates for improved data collection and optimised training in IR
Profile: Aghiad Al-Kutoubi
Working towards a safer IR department: "Developing common purpose and objectives"
...
Thierry De Baère (Gustave Roussy; Villejuif, France) talks to Interventional News about the rationale behind setting up the Initiative on Superselective Conventional Transarterial Chemoembolization (INSPIRE), which aims to bring Asian and European experts together in order to collaborate on standardising cTACE...
The Society of Interventional Oncology (SIO) has declared Mayo Clinic, Rochester, USA as the first of 10 sites in the USA and Europe approved for enrolment on the society’s primary clinical trial ‘Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM), Prospective...
Cagent Vascular has announced the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty.
The study was led by Marianne Brodmann (Medical University of Graz, Graz, Austria). This subanalysis compared their PRELUDE-BTK subset to a...
Photon-counting detector computed tomography (CT) reduces the amount of contrast needed for CT angiography (CTA) while maintaining image quality, according to a new study published in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA).
The...
Surmodics recently announced it has received a letter from the US Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).
In the letter, the FDA indicated that the application is not...
IceCure Medical has shared in a press release that it has received a Notice of Allowance from the US Patent and Trademark Office for its patent application titled 'Cryogen Pump'. The patent will be in effect until February 2040 and...
Delcath Systems has shared in a press release the publication of updated results from the phase 1b CHOPIN Trial, conducted at Leiden University Medical Center (Leiden, The Netherlands) on the use of the Delcath Chemosat hepatic delivery system with...
A team of specialists at Ulis Hospital (Ulis, Ukraine) has recently reported that the quality-of-life of the two pancreatic cancer patients treated with tumour-specific electroporation (TSE) in September 2022 continues to improve. These two unresectable, locally advanced pancreatic cancer...
Both the Andreas Gruentzig Lecture at this year’s Cardiovascular and Interventional Radiological Society of Europe meeting (CIRSE; 10–14 September, Barcelona, Spain) and a presentation of interim data at the ‘New Frontiers’ FIRST@CIRSE session informed delegates of the innovative future...
A phase II clinical study on a trimodality therapy (START-FIT), conducted by the Departments of Surgery and Clinical Oncology, School of Clinical Medicine, University of Hong Kong (HKUMed; Hong Kong), has found that nearly 50% of patients with inoperable,...
Interventional News’ most popular stories as 2022 came to a close included news of a US Food and Drug Administration clearance for a new radiofrequency ablation (RFA) system; CE mark approval for a radiation protection system; results of a...
Inari Medical has announced that the first patient has been enrolled in DEFIANCE, a prospective randomised controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only....
In a newly released “focused update” to their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice on the surveillance and management of patients treated with the Nellix endovascular...
Viz.ai has announced the launch of Viz Vascular Suite—artificial intelligence (AI)-powered software enabling vascular care teams to automatically detect and triage care for suspected pulmonary embolism, right heart strain, aortic dissection, and abdominal aortic aneurysm (AAA). The company submitted...
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of calcified plaque in patients with peripheral arterial disease (PAD). The study is intended to...
Medtronic has announced the first patient enrolment in the ADVANCE Trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs stent graft system and GORE Excluder AAA device family systems. The ADVANCE...
Rivermark Medical has announced the successful first-in-human (FIH) use of its FloStent System as part of the company's RAPID-1 FIH clinical study. The procedures were performed on 15 patients by Principal Investigator (PI) and urologist Ingrid Perscky Arravanti (Universidad...
GE Healthcare announced it has entered into an agreement to acquire Imactis, an innovator in computed tomography (CT) interventional guidance across an array of care areas. Imactis is a France-based company that was founded in 2009 by Stéphane Lavallée and Lionel...
Today, Penumbra announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.
"Lightning Flash features Penumbra's novel Lightning intelligent aspiration technology, now with dual clot detection algorithms," the company notes in a...
Instylla has announced the enrolment of the first patient in the HALT study for the treatment of peripheral arterial bleeds. The HALT study is a prospective, multicentre, single-arm study to evaluate the safety and effectiveness of the Embrace hydrogel...
Synchron has announced that the medical journal JAMA Neurology has published peer-reviewed, long-term safety results from a clinical study in four patients with severe paralysis implanted with the company’s first-generation Stentrode neuroprosthesis device. The study found that it is...
Fluidx Medical has released information regarding the success of the IMPASS Embolic Device in in vivo research related to middle meningeal artery (MMA) embolizations which can be used to treat chronic subdural haematomas (CSDH) on the surface of the...
Speaking to Interventional News at the recent Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain), Arthur Rocha (São Paulo, Brazil), from professor Carnevale’s team, shares the development of an optimised imaging workflow—which consists of...
Lydus Medical is pleased to announce that the Vesseal has received US Food and Drug Administration (FDA) 510(k) clearance. The Vesseal is a microvascular anastomosis suture deployment system, for standardised omnivessel anastomoses, enabling simple, fast, safe, and effective procedures.
An...
Paula Novelli, who is associate professor of interventional radiology (IR) at the University of Pittsburgh Medical Center (Pittsburgh, USA) put her own spin on a British Society of Interventional Radiology (BSIR) annual scientific meeting (2–4 November, Glasgow, UK) presentation...
Interventional News covered a whole range of the specialty's news during 2022, but readers' attention was most piqued by acquisitions (Boston Scientific's of Obsidio and Bentley's of the GoBack catheter); study results from meetings that highlighted the "potential" and...
AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases and advance development and preclinical work...
Cardiovascular Systems (CSI) announced that Innova Vascular (Innova) has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.
CSI intends to acquire and commercialise each of...
IceCure Medical, developer of the minimally-invasive ProSense System for cryoablation, which destroys tumours by freezing, today announced interim results from the ICESECRET study for the treatment of patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery....
ReCor Medical and its parent company Otsuka Medical Devices have announced the appointment of Lara Barghout as president and chief executive officer of ReCor.
Barghout will lead the ReCor business strategy and organisation in the global commercialisation of ReCor’s Paradise...
Lung nodule biopsies performed with new robotic bronchoscopy technology may be safer and more effective than those done by traditional methods, a study by researchers at the University of Texas Southwestern (UTSW; Dallas-Fort Worth, USA) suggests.
UTSW was among the...
RF Medical is a Korean thermal ablation system manufacturer and the creator of the Mygen M-3004 generator and specialised electrodes including Myoblate. Both of these products have been cleared by the US Food and Drug Administration (FDA) and are...
VentureMed Group, a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced data presented at the VEITHsymposium, (15–19 November, New York, USA)....
Corindus has been rebranded to Siemens Healthineers Endovascular Robotics and will sit as a dedicated business within the Advanced Therapies area of Siemens Healthineers, the company has announced.
This brand unification is the final step of the company integration process...
Efemoral Medical has today announced the closing of its US$4.9 million preferred Series A1 round. Supported by existing investors as well as an experienced cohort of new investors, the proceeds will further Efemoral's device development and expand enrolment in...
Cook Medical announces John A Kaufman (Cook Medical, Bloomington, USA) will be joining as its chief medical officer, effective July 2023. With Kaufman’s expertise and new appointment to this position, Cook is taking a significant step in its clinical...
Boston Scientific has announced that it will make a partial offer to acquire a majority stake, up to a maximum of 65%, of shares of Acotec Scientific, a Chinese medical technology company that offers solutions designed for a variety...
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023.
Kyriakides informed health ministers from the EU’s...
Reto Bale (Innsbruck, Austria) talks to Interventional News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) about some of the key benefits of using navigation and robotics during interventional radiology and oncology...
Interventional News’ most popular stories last month included news of a US Food and Drug Administration pre-market approval submission of an ultrasound renal denervation system, as well as that of receipt of aforementioned approval for a drug-coated angioplasty balloon...
Delcath Systems announced the publication of a retrospective analysis of patients who underwent a percutaneous hepatic perfusion procedure (PHP) with Chemosat for the treatment of either inoperable intrahepatic cholangiocarcinomas (iCCA) or extrahepatic cholangiocarcinoma (eCCA) with liver metastases.
The article 'New...
Data have been presented for the first time at the Paris Vascular Insights (PVI) conference (23–25 November, Paris, France) from the ABISS trial, which compared drug-coated balloon (DCB) with plain-balloon angioplasty for arteriovenous fistula (AVF) stenosis.
ABISS was a physician-designed...
Egg Medical, a medical device company commercialising technologies to reduce scatter radiation exposure during interventional angiographic procedures, has announced that it has achieved CE mark for the EggNest XR radiation protection system. The EggNest protects the entire interventional team...
Royal College of Radiology (RCR) president Kath Halliday (Nottingham University Hospitals, Nottingham, UK) gave a presentation to the British Society of Interventional Radiology (BSIR) annual scientific meeting (2–4 November, Glasgow, UK) exploring how new technologies and infrastructural reforms can...
A minimally invasive treatment for carpal tunnel syndrome provides complete and long-term relief to patients without the use of corticosteroids, according to research presented at the annual meeting of the Radiological Society of North America (RSNA; 27 November–1 December,...
Neurologica, a subsidiary of Samsung Electronics, has announced that its head-to-toe trauma imaging solution—the BodyTom 64 point-of-care mobile computed tomography (CT) scanner—has received 510(k) clearance from the US Food and Drug Administration (FDA) for commercial use in the USA.
Based on...
For patients with early-stage renal cell carcinomas (RCCs) that measure between 3 and 4cm, cryoablation yields a lower risk of cancer-related death compared to thermal ablation, reports a preliminary study in the Journal of Urology.
"In contrast, for patients with...
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion for ‘more freedom of action in the procurement of medical products for supply of the...
Otsuka Medical Devices and ReCor Medical, a subsidiary of Otsuka, announce the filing of the pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for the Paradise ultrasound renal denervation (uRDN) system in the treatment of...
In the opening session of the British Society of Interventional Radiology (BSIR) annual scientific meeting 2022 (2–4 November, Glasgow, UK) titled ‘What’s up, Doc?’, four faculty members spelt out for attendees what they consider to have been the most...
Findings from a recent prospective study show promising safety and patient outcomes data for locally advanced and borderline resectable pancreatic cancer treatment using ablative stereotactic magnetic resonance imaging (MRI)-guided on-table adaptive radiation therapy, also known as SMART. Approximately 25%...
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Lambros Tselikas (Villejuif, France) speaks to Interventional News about a recent retrospective study evaluating Liver ASSIST Virtual Parenchyma—the results of which he presented at the Cardiovascular and Interventional...
“If it were easy, this session would not be here.” These are the words of Jens Ricke (University Hospital Munich, Munich, Germany), who drew attention to the self-evident nature of the difficulties involved in multidisciplinary collaboration during an expert...
Hospices Civils de Lyon (HCL; Lyon, France) has acquired Epione, the robotic platform developed by Quantum Surgical (QS) that is designed to enable minimally invasive ablations of tumours in the abdomen. This was announced by QS in a press...
Varian, a Siemens Healthineers company, announced today that the first trial participant has been treated as part of GENESIS II, a study of Embozene microspheres for genicular artery embolization (GAE) as treatment of mild-to-moderate knee osteoarthritis. GENESIS II is...
The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI population,” and has a primary patency rate of 80% at 12 months in a per-protocol analysis population. Ramon Varcoe (Prince...
Amanda Smolock (Medical College of Wisconsin, Milwaukee, USA) discusses how her practice operates, using microwave ablation nearly exclusively for primary and metastatic liver tumours targetable under ultrasound (US) and/or computed tomography (CT) guidance.
Patients are typically discussed at a multidisciplinary...
Terumo Europe has announced in a press release that it welcomes the guidance released by the National Institute for Health and Care Excellence (NICE) mentioning that microwave ablation can be used provided standard arrangements are in place for clinical governance,...
Soundbite Medical Solutions announced that it has entered into an exclusive license agreement with VFLO Medical (VFLO).
Pursuant to the agreement, Soundbite has granted VFLO an exclusive license for certain proprietary products including its SoundBite crossing system and the...
VentureMed Group has announced new data presentations on the treatment of peripheral arterial disease (PAD) with drug-coated balloon (DCBs) in addition to 12-month AV Registry Data. These presentations will be given as part of the VEITH Symposium Annual Scientific...
Interventional News’ most popular content last month featured a report on the need for greater interventional radiology (IR) service coverage in rural areas of the USA; news of a US Food and Drug Administration (FDA) premarket approval (PMA) submission...
Mark Little (Royal Berkshire Hospital, Reading, UK) brought delegates up to speed on genicular artery embolization (GAE) for knee osteoarthritis over two sessions at the recent British Society of Interventional Radiology (BSIR) annual scientific meeting (2–4 November, Glasgow, UK)....
The Society of Interventional Radiology (SIR) published a position statement deeming endovascular thrombus removal “an acceptable treatment option in selected patients with acute iliofemoral deep vein thrombosis .” The position statement is published online on the Journal of Vascular and...
In this video, Vincent Vidal, Alexis Jacquier and Pierre-Antoine Barral share their testimonies about the Allia IGS 7.
This video is sponsored by GE Healthcare.
Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter developed by TriReme Medical for the treatment of patients with peripheral artery disease (PAD)...
Xeltis announced today the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access grafts, dubbed ‘Axess’.
The first two patients have been successfully implanted as part of the AXESS European pivotal trial at AZ Sint-Jan Brugge-Oostende AV...
Year three of the COVID-19 pandemic and yet much now feels unrestricted and ‘back to normal’. This can certainly be said of meetings—at least in Europe and the USA—which, throughout 2020 and some of 2021, took place online, but...
ReCor Medical and its parent company, Otsuka Medical Devices, announced consistent and significant blood pressure-lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. The results...
Medtronic has announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The late-breaking data were presented at the American Heart Association (AHA) Scientific Sessions 2022 (5–7 November, Chicago, USA). With this news, Medtronic has...
The first results from the BEST-CLI randomised controlled trial (RCT) of 1,830 patients show that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularisation strategy for patients with chronic limb-threatening ischaemia (CLTI) who are...
Two datasets presented during the late-breaking clinical trials session at The VEINS (Venous Endovascular Interventional Strategies) 2022 (30–31 October, Las Vegas, USA)—the latest results from CLOUT and a propensity score-matched analysis of CLOUT versus ATTRACT—bolster the evidence base for...
The management of renal cancer patients featured prominently at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting (10–14 September, Barcelona, Spain), with discussions around patient selection and treatment planning preceding talks on the key therapeutic...
Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA sirolimus drug-coated balloon (DCB) versus paclitaxel DCB angioplasty for the treatment of peripheral artery disease...
Gerd Grözinger (Tübingen, Germany) chats with Bernhard Gebauer (Berlin, Germany) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) about some of the difficulties associated with treating patients with pulmonary embolism...
Synchron has announced that enrolment in the COMMAND trial has commenced at the University of Pittsburgh in Pittsburgh, USA.
The COMMAND trial is an early feasibility study funded by the National Institutes of Health (NIH) that will primarily assess safety...
Transit Scientific has announced that the XO RX 2.2Fr and XO RX 3.8Fr platform has received US Food and Drug Administration (FDA) clearance to crack, break and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula-associated lesions.
"We have demonstrated...
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Mechanical thrombectomy with the ClotTriever and FlowTriever systems (Inari Medical) opens up new possibilities for the management of deep vein thrombosis (DVT) and pulmonary embolism (PE),...
Matthew Gibson (Royal Berkshire Hospital, Reading, UK) will be delivering this year’s British Society of Interventional Radiology (BSIR; 2–4 November, Glasgow, UK) Wattie Fletcher Lecture ‘Survive and thrive in interventional radiology ’. Interventional News spoke with Gibson to glean...
The second day of the CX Aortic Vienna 2022 Digital Edition (24–26 October) saw presentations on dynamic computed tomography angiography (CTA), a device with the potential to bring hologram guidance to vascular procedures and an edited case highlighting the...
“The spine is an area where interventional radiologists play a crucial role in both diagnosis and therapeutic management of a variety of pathologies”.
Dimitrios Filippiadis is associate professor of diagnostic and interventional radiology (IR) at the National and Kapodistrian...
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Marco van Strijen is an interventional radiologist at St Antonius Ziekenhuis (Nieuwegein, The Netherlands) who specialises in non-vascular interventions and interventional oncology. Image-guided procedures feature heavily in his practice, Van Strijen tells Interventional...
Interventional News 88 Highlights:
The importance of putting patients first during multidisciplinary collaboration
A discussion with IR societies on the future of hybrid meetings post-COVID
Profile: Dimitrios Filippiadis
An exploration of the latest tech developments in IR
Advertorial: Micromate...
Interventional News 88 Highlights:
The importance of putting patients first during multidisciplinary collaboration
A discussion with IR societies on the future of hybrid meetings post-COVID
Profile: Dimitrios Filippiadis
An exploration of the latest tech developments in IR
Advertorial: Micromate...
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In the USA, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published US data from the Vascular Quality Initiative (VQI),...
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Cordis today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance.
A press release notes that the agreement includes an initial investment of US$35 million and US$200 million payment upon closing in 2023, regulatory achievement...
Cardiovascular Systems Inc (CSI) has announced the full market release of the 2.00 Max Crown for peripheral orbital atherectomy systems (2.00 Max Crown).
CSI notes in a press release that the 2.00 Max Crown is uniquely designed to enable simultaneous modification...
Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the company's Abre venous self-expanding stent system, intended for the treatment of...
Interventional radiology (IR) was officially born on January 16, 1964, when Charles Dotter performed the first arterial angioplasty at the Department of Radiology at Oregon Health and Science University (Portland, USA). We still can see the prescription Dotter received...
Interventional News’ most popular content last month included news of the acquisition of a new catheter by Bentley, the announcement of the final patient enrolled in a liquid embolic study, latest data from the SAVAL trial of a drug-eluting...
XACT Robotics announced that its ACE Xtend remote control unit received US Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room. The first-of-its-kind feature for...
Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention Symposium (AMP; 9–11 October, Lugano, Switzerland).
The SWING study is a prospective, multicentre, single-arm feasibility study...
A new report from a joint taskforce of the American College of Radiology (ACR) and the Society of Interventional Radiology (SIR) recommends improved access to interventional radiologists in small and rural areas. The taskforce was formed to explore strategies for...
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration (FDA).
The Detour system, which earned FDA Breakthrough Device Designation, is a unique therapy that allows...
Thomas Rand (Klinik Florisdorf, Vienna, Austria) recently presented on the preliminary results to 12 months of the Motiv bioresorbable scaffold (Reva Medical) postmarket trial at the recent Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14...
Xeltis today announced what it describes as “very promising” preliminary efficacy and safety results from one of the centres participating in the AXESS study—a first-in-human (FIH) clinical trial of its restorative haemodialysis access graft, Axess.
The company has also reported...
After the disappointment of a few failed randomised controlled trials (RCTs), transarterial radioembolization (TARE) is finally back in the spotlight. And interventional radiologists (IRs) are learning from these past failures to shape the future.
Despite negative results, former trials have...
Results of the FLASH registry demonstrate the “excellent safety profile” of the FlowTriever system (Inari Medical) in 800 “real-world” patients. This is according to Catalin Toma (University of Pittsburgh Medical Center, Pittsburgh, USA), who presented outcomes for the full...
Paediatric interventional radiologist Alex Barnacle (Great Ormond Street Hospital, London, UK) gave the Josef Roesch Lecture at the Cardiovascular and Interventional Radiological Society of Europe 2022 meeting (CIRSE; 10–14 September, Barcelona, Spain), choosing to present on the subject of...
Terumo Medical Corporation has announced late-breaking data showing the safety and efficacy of radial to peripheral (R2P) interventions with the R2P Misago self-expanding peripheral stent in lower extremity endovascular interventions via a radial approach. The results were presented at...
Truveta announced a strategic collaborative agreement with Boston Scientific to improve long-term patient care and gain insights into healthcare disparities. Through this collaboration, Boston Scientific researchers will be able to access data from Truveta, which contain de-identified medical records...
Guerbet announced that the US Food and Drug Administration (FDA), after priority review, has approved Elucirem (Gadopiclenol), a new macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced magnetic resonance imaging (MRI).
Elucirem (Gadopiclenol) is a new macrocyclic GBCA with...
Penumbra and Asahi Intecc, a Japanese medical device manufacturer, announced that they will collaborate to introduce Penumbra’s Indigo Aspiration System into the Japanese market upon regulatory approval.
“By bringing together our newest innovations with Asahi’s leadership and expertise in the...
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) saw presenters explore artificial intelligence (AI), its current role in interventional radiology (IR), and how the two will evolve together to shape innovative...
Day one of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) put a strong focus on peripheral arterial disease (PAD). At a FIRST@CIRSE session, Hans van Overhagen (Haga Teaching Hospital, Den...
Stryker has announced in a press release that its OptaBlate bone tumour ablation system (OptaBlate) has received 510(k) clearance from the US Food and Drug Administration (FDA). The addition of the OptaBlate technology to Stryker's Interventional Spine (IVS) portfolio...
Medtronic announced that it has recently received CE mark for its Radiant balloon-expandable covered stent, the first and currently, only, covered stent indicated for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system.
Used together,...
Findings from the RADIANCE II randomised pivotal trial, presented at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA), “confirm that ultrasound renal denervation lowers blood pressure across the spectrum of hypertension”.
RADIANCE II—results of which were described...
Sirtex Medical announced that the Brazilian National Agency of Supplementary Health (ANS) approved SIR-Spheres Y-90 resin microspheres for the treatment of intermediate- and advanced-stage hepatocellular carcinoma (HCC) in Brazil.
In an update to its List of Health Procedures and Events, ANS...
Bentley today announced that it has acquired the rights of the GoBack catheter from Upstream Peripheral Technologies.
“The acquisition of the GoBack catheter marks the start of inorganic growth for Bentley,” said Sebastian Büchert, Bentley's CEO. “We launched our first...
Merit Medical Systems has announced the US commercial release of the Prelude Roadster guide sheath. The Prelude Roadster is the newest addition to the Merit Vascular-Peripheral Access portfolio, which includes introducers and other products, including access kits, vessel dilators,...
ABK Biomedical has announced US Food and Drug Administration (FDA) 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumours.
Aravind Arepally, chief medical officer of ABK Biomedical said: “The evolution of...
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“I am finally very confident I have a device that takes out all the thrombus,” stated Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany)...
Interventional News' popular stories last month included acquisitions by Boston Scientific and Gore, studies of deep vein thrombosis and peripheral arterial disease treatments and, on the subject of the latter, research into the racial disparities affecting patients who receive...
Interventional News 87 Highlights:
Ten-year data on PAE for benign prostatic hyperplasia
The success of interventional radiology outpatient clinics
Profile: Alban Denys
Diversity in IR: women in leadership and tackling toll of racism on health
Advertorial: Quality Ablation with...
Interventional News 87 Highlights:
Ten-year data on PAE for benign prostatic hyperplasia
The success of interventional radiology outpatient clinics
IR awareness: an initiative run by and for trainees
Profile: Alban Denys
Advertorial: TACE with degradable starch microsphere in European...
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At the onset of the COVID-19 pandemic in early 2020, healthcare systems across the globe were forced, almost overnight, to adapt to a new reality. No corner of the healthcare landscape has been...
The European Society of Cardiovascular and Interventional Radiology (CIRSE) will host its 38th annual meeting in Barcelona from September 10 until September 14. Around 5,000 healthcare professionals from around the world are expected to attend more than 400 lectures in...
Interventional Systems has launched a new subscription service for Micromate with three package levels offering the miniature robotic system including the latest planning and navigation station, as well as disposable accessories and specialised services. The subscription fee is fixed and...
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Thomas Zeller (Bad Krozingen, Germany) talks to Vascular News about the iliCo study, of which he is co-principal investigator, and which is designed to evaluate the...
Penumbra announced today that its RED reperfusion catheters have secured a CE mark and are now commercially available in Europe. The catheters are part of the company’s Penumbra system, which is a fully integrated mechanical aspiration thrombectomy system designed to...
Royal Philips today announced new milestones in the development of the world’s first spectral detector angio computed tomography (CT) solution— Philips Spectral Angio CT suite—bringing the company’s breakthrough spectral CT imaging technology into an integrated hybrid angio CT suite....
This advertorial is sponsored by PharmaCept.
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recently incorporated transarterial chemoembolization with degradable starch microspheres (DSM-TACE) into its guidelines for hepatic transarterial chemoembolization.¹ In addition to society backing, experts are also in...
Andrew Wigham (Oxford, UK) and Rick De Graaf (Friedrichshafen, Germany) discuss the current state of deep vein thrombosis (DVT) treatment at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany), with both noting that “a massive problem” in...
Fluidx Medical announces completion of trial enrolment for its GPX embolic device. In this multicentre trial, GPX was used to treat a variety of primary and metastatic tumours, renal adenoma tumours, and a range of other arterial and venous...
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“The Changing Face of a Dialysis Patient” was the central theme at BD’s EMEA ESKD Summit (17–18 May 2022, Madrid, Spain)—a meeting that championed patient-centric, multidisciplinary...
Inari Medical has announced planned enrolment of the DEFIANCE randomised controlled trial (RCT), which is designed to compare the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.
The trial will...
This advertorial is sponsored by CASCINATION AG.
Ablation is used to destroy or shrink tumours in the liver, lung, kidney, bone, and other organs. In recent decades, image-guided ablation has become integral to modern cancer therapy with curative or palliative...
Alban Denys is a French-Swiss interventional radiologist who was one of the founding members of the Society of Interventional Oncology (SIO). He has held the position of chairman of the European Conference on Interventional Oncology (ECIO) and developed and...
Indrajeet Mandal, a second-year radiology registrar at Oxford University Hospitals NHS Foundation Trust (Oxford, UK), speaks to Interventional News about the interventional radiology (IR) awareness initiative that he co-founded in 2019—IR Juniors.
Mandal along with Niall Burke (NHS Lothian,...
Vascular Therapies has announced that the first patient in the ACCESS 2 clinical trial was enrolled by Nikhil Kansal at Harbor-UCLA Medical Center in Torrance, USA.
The Phase 3 prospective randomised ACCESS 2 study will enrol 120 patients from centres in the...
Reto Bale (Medizinische Universität Innsbruck, Innsbruck, Austria) gave a presentation titled ‘Stereotactic thermal ablation—can it break the current limits?’ at the 2022 European Conference of Interventional Oncology (ECIO; 24–27 April, Vienna, Austria). A key takeaway was that although the...
ŌNŌCOR has announced in a company press release that the ŌNŌ endovascular retrieval system was used to remove a large central-line-associated thrombus from the right atrium in a teenage patient.
The team at Children's Hospital Los Angeles (CHLA; Los Angeles, USA)...
Teleflex has announced a new agreement with FundamentalVR, a company providing virtual reality (VR) integration for medical simulation. The agreement will provide Teleflex with a VR training platform to accelerate the effective use of the company’s UroLift 2 system,...
A study recently published in the World Journal of Surgery claims to be the first to provide comprehensive population-level data on the epidemiology of lower extremity amputation (LEA) in a Latin American low- and middle-income country (LMIC). The investigators...
The first US patient has been enrolled in the US Food and Drug Administration (FDA) SELUTION4BTK (below-the-knee) clinical trial evaluating Selution SLR, MedAlliance's novel sirolimus-eluting balloon. This follows investigational device exemption (IDE) approval in the USA in May 2022,...
BD has announced the start of enrolment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The PREVISION trial is a prospective, multicentre, single arm, non-randomised study designed to evaluate the safety of the BD sirolimus DCB in...
Building upon “pioneering work” at University of Texas Southwestern (UTSW) Medical Center (Dallas, USA), investigators recently reported the results of a clinical trial exploring the role of stereotactic ablative radiation therapy (SAbR) for patients with a handful of metastases, or so-called oligometastatic...
A new imaging device at University of Texas (UT) Southwestern (Dallas, USA) is making complex aortic repairs safer for patients and operating room staff by dramatically reducing their exposure to radiation. The device, known as Fiber Optic RealShape (FORS;...
Iodinated contrast media agents, namely Omnipaque (iohexol) and Visipaque (iodixanol), are frequently used in imaging studies for both diagnosis and treatment. GE Healthcare, the manufacturer, had to shut its plant in Shanghai, China, due to local COVID-19 policies, which...
In a study recently published in Circulation, researchers found that Black adults underwent significantly more endovascular peripheral vascular interventions (PVI), were treated for more advanced disease and were also more likely to experience adverse outcomes following PVI procedures, including amputation and death. Interventional...
CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The...
Boston Scientific has announced the acquisition of Obsidio, a privately held company that has developed the Gel Embolic Material (GEM) technology used for embolization of blood vessels in the peripheral vasculature.
Recently cleared by the US Food and Drug Administration...
Ramona Gupta (Northwestern University, Chicago, USA) addresses the issue of recurrent varicose veins, highlighting in particular the “multiple tools” now at physicians’ disposal to treat the problem.
Superficial venous insufficiency and varicose veins affect approximately 23% of adults worldwide. Treatments...
Gore has announced the acquisition of InnAVasc Medical, a privately held medical technology company focused on advancing care for patients with end-stage renal disease who utilise graft circuits for dialysis treatment.
Jeffrey Lawson and Shawn Gage from Duke University School...
Royal Philips today announced an important milestone in the evolving standard of care for treating patients with peripheral vascular disease: the establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity arterial...
Delcath Systems has announced the publication of a retrospective analysis of patients who underwent a percutaneous hepatic perfusion procedure (PHP) with Chemosat at three European centres, one in the Netherlands and two in Germany, between February 2014 and December 2019. The study,...
AngioDynamics recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.
The FDA recently cleared the expanded indication for the Auryon system’s 2mm...
Fluidx Medical disclosed study results examining extent of vessel filling using the GPX embolic device compared to microspheres, a common treatment for many types of tumours.
"GPX is demonstrating deep distal vessel penetration," said Ryan O'Hara, interventional oncologist at the University...
Selution SLR, MedAlliance's sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).
This comes only...
Shape Memory Medical announced today that its 1,500th patient has been treated, marking a significant milestone for the company’s portfolio of shape memory polymer embolotherapy devices—the Impede embolisation plug family and the TrelliX embolic coil. The patient was treated...
Prostate conditions and their treatment proved popular reading topics during the month of July. Interventional News reported on this subject from various angles—from an award-winning abstract on prostatic artery embolization for benign prostate hyperplasia (BPH) and the US Food...
Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company's Magic Touch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease...
Mark Little (Royal Berkshire NHS Foundation Trust, Reading, UK) described the emergence of, and advancement within, musculoskeletal (MSK) embolotherapy as “fast-paced” during his presentation on the trends and developments in the field, delivered at this year’s European Conference on...
Transit Scientific has reported multiple successful peripheral vascular procedures with the XO Cross catheter platform utilising pedal retrograde access.
The non-tapered 2Fr XO Cross 14 microcatheter in 90cm, 135cm, and 175cm lengths is designed to facilitate guidewire support, guidewire...
A database study titled ‘Unplanned 30-day readmissions and in-hospital outcomes for the management of submassive and massive acute pulmonary embolism: Catheter-directed versus systemic thrombolysis’ has produced results that could provide some of the evidence base for preference of catheter-directed...
Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US commercial launch of the device, which will begin in early August, according to the company.
Biotronik...
Instylla, a company developing liquid embolics for peripheral vascular embolotherapy, recently announced two publications that evaluated the Embrace hydrogel embolic system (HES) in preclinical porcine haemorrhage models.
In a Journal of Vascular and Interventional Radiology (JVIR) publication, Gandras et al...
Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm over-the-wire Turbo-Elite laser atherectomy catheter.
This...
ReCor Medical and Otsuka Medical Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its...
About 6.5 million Americans over the age of 40 suffer from peripheral arterial disease (PAD). In the USA, Black adults in their 50s are at least twice as likely to suffer from PAD as their white counterparts, a disparity...
Monica Webb Hooper, deputy director of the National Institute on Minority Health and Health Disparities (Bethesda, USA) works to help reduce healthcare disparities and improve minority health. Among the subjects of her presentation at the second plenary of the...
As part of the ‘Trauma and Emergencies’ session at this year’s European Conference on Embolotherapy (22–25 June, Nice, France), conference deputy chairman Otto van Delden (Amsterdam University Medical Centers, Amsterdam, The Netherlands) presented blunt abdominal trauma cases to delegates...
The University of Texas at Arlington (UTA; Arlington, USA) announced in June 2022 that Kytai Nguyen, a UTA bioengineering professor, had received National Institutes of Health (NIH) funding to develop a dual-capability biodegradable nanoparticle for use in treating peripheral...
Embolx, a medical device company developing microcatheters for arterial embolization procedures to treat cancerous tumours, benign prostatic hyperplasia, and uterine fibroids, has announced that the company has filed a 510(k) to the US Food and Drug Administration (FDA) for...
Subtle Medical, a key provider of artificial intelligence (AI) solutions for medical imaging, and Siemens Healthineers have officially announced the integration of Subtle Medical's SubtleMR image-enhancement software into the new reconstruction pipeline of Siemens Healthineers, Open Recon. The launch...
Cordis has announced the start of the RADIANCY premarket clinical study in Europe.
A press release details that RADIANCY is a prospective, multicentre, single-arm study to assess the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system intended...
SoniVie today announced that on 30 May this year the first patient was treated with its renal artery denervation Tivus therapeutic intravascular ultrasound technology, as part of the recently US Food and Drug Administration (FDA) investigational device exemption (IDE)-approved REDUCED1...
A prospective, multicentre study involving the Covera vascular covered stent (BD) has confirmed the benefits of immediate, post-percutaneous transluminal angioplasty (PTA) placement of the device in treating arteriovenous graft (AVG) venous anastomotic stenosis when anatomically and clinically suitable. Writing...
Biotronik announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
The BIO REACT study was designed to better understand when...
Access Vascular, Inc. (AVI) has shared initial findings from a retrospective review of patient records according to a press release. These demonstrate an increase in dwell times compared to other commercially available devices and no complications when using AVI’s...
Philips has announced that its SmartSpeed artificial intelligence (AI)-powered magnetic resonance (MR) acceleration software has received US Food and Drug Administration (FDA) 510(k) clearance. It is one innovation within the portfolio of smart Philips MR systems showcased at the...
Robert Jones (Birmingham, UK), Interventional radiologist and president of the Vascular Access Society of Britain and Ireland (VASBI), tells Renal Interventions at the Endovascular Access meeting (EVA; 24–25 June, Patras, Greece) that there are still significant untapped areas for...
Ra Medical Systems has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system. A company press release details that the catheter features enhancements...
Konica Minolta Healthcare Americas has announced that the company’s Dynamic Digital Radiography (DDR) technology, enabling the visualisation of anatomy in motion, will be available on the mKDR Xpress mobile X-ray system. The mobile system will also be compatible with...
Tiago Bilhim (Saint Louis Hospital, Lisbon, Portugal) presented during the Scientific Paper session at this year’s European Conference on Embolotherapy (22–25 June, Nice, France), and won the award of best abstract for his and co-authors’ ‘Long-term outcome of prostatic...
Among the most popular pieces from last month are reports on papers delivered at the Society of Interventional Radiology (SIR) 2022 Annual Meeting (11–16 June, Boston, USA), two stories of innovations in pain management, and a write-up of a...
Merit Medical has announced the successful enrolment of the first patient in its WRAP registry study in a press release. This study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving...
Teleflex has announced the results of several research studies that further support the safety and efficacy of the UroLift system for men living with enlarged prostate, benign prostatic hyperplasia (BPH), or those who have a wide range of prostate...
Cydar Medical, in partnership with King’s College London, has initiated the ARIA study—a randomised controlled trial to assess the clinical, technical and cost-effectiveness of a cloud-based, artificially intelligent image fusion system in comparison to standard treatment to guide endovascular...
Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that it has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) for a clinical comparative study of the...
Transit Scientific had shared via press release successful outcomes on multiple fistula and graft cases using its XO Score sheath platform, a first-of-its-kind metal-alloy scoring, cutting, and constraining structure (CS) device, along with off-the-shelf percutaneous transluminal angioplasty (PTA) balloons.
XO...