Jocelyn Hudson

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Advance Serenity hydrophilic PTA balloon catheter now available in the USA

Cook Medical recently announced that the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The...

New data reconfirm long-term safety profile of the Philips Stellarex low-dose...

Royal Philips recently announced the four-year results from the ILLUMENATE European randomised controlled trial (EU RCT). The Stellarex drug-coated balloon (DCB) cohort demonstrated similar...

MERLION trial six-month outcomes presented at VIVA late-breaking trial session

Six-month clinical outcomes of the MERLION trial were presented as part of the VIVA Late-Breaking Clinical Trials Livesteam (25 June), by Tjun Tang (Singapore...

Intact Vascular announces positive one-year data from TOBA II BTK clinical...

tack
Intact Vascular announced the positive one-year results from its Tack optimised balloon angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA)...

Real-world analysis demonstrates lower long-term mortality after DCB angioplasty of femoropopliteal...

In a real-world retrospective analysis, recently published in JACC: Cardiovascular Interventions, the long-term mortality rate was lower after drug-coated balloon (DCB) angioplasty than after plain...

INFINITY Angioplasty Balloon Catheter receives 510(k) clearance

The Infinity Angioplasty Balloon Company has announced that its balloon platform—the INFINITY Angioplasty Balloon Catheter—has been cleared by the US Food and Drug Administration...

Surmodics receives CE mark for its SurVeil drug-coated balloon

Surmodics logo
Surmodics recently announced it has received CE mark certification in the European Union for its SurVeil drug-coated balloon (DCB). “I am excited about the potential...

MHRA: Warning to be added to paclitaxel device IFUs in Europe

In a new field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will...

Lipidol Ultra-Fluid recevies approval for use in cTACE by China NMPA

Guerbet has announced the approval of an additional indication for Lipiodol Ultra-Fluid by the China NMPA (National Medical Products Administration) for use in transarterial...

CX 2020 LIVE: Vascular Access session showcases new technologies, while debate...

The CX 2020 LIVE Vascular Access Consensus session sparked global interest, with chair Nick Inston (Birmingham, UK) and moderator Domenico Valenti (London, UK) taking...

CX 2020 LIVE: Strong support for relining peripheral arteries and rivaroxaban use for widespread atherosclerosis 

In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...

Shockwave Medical announces that CMS has created new codes for intravascular...

Shockwave Medical announced today that the Centers for Medicare & Medicaid Services (CMS) has issued new codes for intravascular lithotripsy (IVL) procedures performed in...

CX 2020 LIVE aortic arch discussion highlights importance of underlying pathology...

Last week week, the CX 2020 LIVE agenda turned to the technically challenging topic of aortic arch interventions. Through presentations, discussion, and polling, the...

CX 2020 LIVE gains CME accreditation: Attendees from 79 countries participate live

In a boost for vascular education, the CX 2020 LIVE sessions have been granted European Union (EU) and US reciprocal Continuing Medical Education (CME) points in recognition of its...

VasQ external support awarded breakthrough device designation by the FDA

VasQ external support
The US Food and Drug Administration (FDA) has designated Laminate Medical’s VasQ external support for the creation of arteriovenous fistulas (AVF) in haemodialysis patients...

CX 2020 LIVE pioneers virtual vascular conference format in COVID-19 era

CX 2020 LIVE came to life online—despite COVID-19—using state-of-the art broadcast technology to bring together more than 1,000 vascular specialists, live, from 95 countries across...

Positive two-year data from ALPS registry of LimFlow system published

LimFlow SA today announced publication of positive two-year data from the ALPS registry of the LimFlow percutaneous deep vein arterialisation (pDVA) system. Results were...

Bluegrass Vascular Technologies announces first US commercial cases with the Surfacer...

Bluegrass Vascular Technologies has announced that the first US commercial cases using the Surfacer Inside-Out access catheter system were completed at Santa Clara Valley...

Getinge introduces Advanta V12 balloon expandable covered stent in larger size

Getinge Advanta V12
Getinge recently announced the launch of its Advanta V12 large diameter stent. According to a press release, Getinge’s Advanta V12 stent has been shown to...

Global support network “will improve the representation of women in endovascular...

While more than 60% of medical students are female, the number of women in endovascular medicine is low, report Bella Huasen and Agnieszka Solberg....

SCAI issues device selection guidelines for aortoiliac arterial interventions

SCAI
The Society for Cardiovascular Angiography and Interventions (SCAI) has released guidelines that provide a comprehensive review of comparative effectiveness data for devices used in...

TOBA III clinical trial results published in the Journal of Vascular...

tack
Intact Vascular has announced the peer-reviewed publication of its Tack optimised balloon angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery. The multi-centre, single-arm,...

VIVA Physicians publishes analysis evaluating mortality and paclitaxel-coated devices

An individual patient-level data (IPD) analysis of the safety of paclitaxel-containing devices (PTXD), conducted by VIVA Physicians, identified an absolute 4.6% increased mortality risk...

FDA clears Aspire MAX mechanical thrombectomy system

Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy...

New study addresses thromboembolic complications in COVID-19 patients

COVID-19
There is an “urgent need” to improve specific venous thromboembolism (VTE) diagnostic strategies and investigate the efficacy and safety of thromboprophylaxis in ambulatory COVID-19...

Global vascular community addresses geographic disparity in pandemic impact and response,...

Last week, the Charing Cross (CX) Symposium 2020 would have taken place in London, UK. To mark the occasion virtually, experts from across the...

First US commercial use of Tack Endovascular System (4F) in BTK...

Intact Vascular has announced the first commercial use of its Tack Endovascular System (4F) in multiple sites across the USA. Notably the first FDA-approved...

First patient enrolled globally in SELUTION SLR study for AV fistulae

MedAlliance SELUTION SLR
MedAlliance has announced enrolment of the first patient in the SAVE (Use of the Selution sirolimus-eluting balloon for dysfunctional AV access treatment indications) study...

Philips and the US government collaborate in ventilator production ramp up...

Royal Philips has announced that the US government and Philips agreed to team up to increase the production of hospital ventilators in its manufacturing...

Virtual VIVA roundtable addresses COVID-19 pandemic

testing
VIVA Physicians recently hosted a virtual roundtable to address COVID-19. Tony Das (Connected Cardiovascular Care Associates, Dallas and BSW Heart Hospital, Plano, USA), one...

ACS defends healthcare workers as PPE shortages lead to acrimony

The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing...

Virtual ACC: Clopidogrel exposure along with aspirin and rivaroxaban should be...

“More bleeding with background clopidogrel, even if not severe by adjudication, may be associated with broad consequences, including discontinuation of therapies. In the absence...

CX 2020 is cancelled due to COVID-19

The 2020 Charing Cross (CX) Symposium that was due to take place next month in London, UK, has been cancelled due to COVID-19.  In full,...

Straub Medical announces first patient treated in USA with Rotarex S atherectomy device 

Straub Medical (United States), the US direct-sales subsidiary of Straub Medical AG (Switzerland), has announced the launch and first intervention performed with the Rotarex S...

National Kidney Foundation releases guideline for vascular access in dialysis patients

kidney scale model
The American Journal of Kidney Diseases (AJKD) has published the National Kidney Foundation's KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update, a completely...

SeQure® microcatheter could help to make embolisation more secure

NOTE: This video is ONLY available to watch in selected countries and geographies Geert Maleux (Leuven, Belgium), one of the first users of the SeQure®...

Okami Medical announces first patients treated with Lobo vascular occluder

Okami Medical has announced the successful completion of the first cases with the Lobo vascular occlusion system. The first offering in the company's product...

Wingman catheter granted expanded indication to cross CTOs in PAD

Wingman catheter by Reflow Medical
Reflow Medical has announced that they have received US Food and Drug Administration (FDA) clearance for an expanded indication for the Wingman crossing catheter...

Ablative Solutions announces publication of data from the Peregrine post-market study

Ablative Solutions has announced that positive six-month results from the Peregrine post-market study demonstrating the safety and efficacy of the company’s CE-marked Peregrine System infusion...

LINC 2020: Geographical “inconsistencies” cast doubt on paclitaxel mortality signal

Peter Schneider at LINC
 Peter Schneider (San Francisco, USA) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the relevance of dose relationship and geographical...

Published real-world experience demonstrates VasQ External Support improves outcomes when adopted...

VasQ external support
Robert Shahverdyan, head of the Vascular Access Center at Asklepios Klinik Barmbek, Hamburg, Germany, has recently published a retrospective analysis of his first 32...

VEITH 2019: “Light at the end of the tunnel” following paclitaxel...

Sean Lyden (Cleveland, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA) about the “tumultuous” year for the industry following the publication of the...

LINC 2020: Real-world evidence shows no increased mortality signal with paclitaxel-coated...

 Dierk Scheinert (Leipzig, Germany) moderates a panel with Eva Freisinger (Münster, Germany) and Thomas Zeller (Bad Krozingen, Germany) to discuss the developments over the...

FDA grants de novo clearance to Bluegrass Vascular for Surfacer system

Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novo classification order for its...

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath Radial Access Long...

XableCath crossing catheters have received CE mark for peripheral use

XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in...

Enrolment of the VasQ external support US pivotal study now complete

Laminate Medical Technologies has announced the completion of enrolment into the VasQ external support US pivotal study. The study was conducted at 17 sites...

Medtronic begins pilot study as part of SPYRAL HTN clinical programme...

kidney scale model
Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN)...

IVL has “changed the dynamics” of facilitating EVAR & TEVAR in...

Frank Arko (Charlotte, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA), about the benefits of using Shockwave Intravascular Lithotripsy (IVL) when performing EVAR...

MedAlliance receives CE mark approval for SELUTION SLR sirolimus drug-eluting balloon...

MedAlliance has announced the award of its first CE mark approval: for SELUTION SLR, a novel sirolimus drug-eluting balloon (DEB), for the treatment of...

LINC 2020: Four-year ILLUMENATE data reaffirm safety profile of Stellarex

Philips today announced four-year results from the randomised controlled ILLUMENATE pivotal trial in the USA. The data show similar mortality rates through four years...

LINC 2020: BD announces long-term safety data for BTK drug-coated balloon

Today at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), BD announced that interim findings from the Lutonix below-the-knee (BTK) investigational...

LINC 2020: High- and low-dose paclitaxel-coated balloons exhibit comparable results at...

At the 2020 Leipzig Interventional Course (28–31 January, Leipzig, Germany), Sabine Steiner (University of Leipzig, Leipzig, Germany) presented one-year results of the COMPARE-RTC of...

LINC 2020: Profusa Lumee oxygen platform may improve clinical management of...

Profusa has announced research findings that suggest the company's Lumee oxygen platform may help improve the clinical management of patients with critical limb ischemia...

LINC 2020: Positive new data for AV access interventions released

New arteriovenous (AV) access results were presented at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), including data on percutaneous AV fistula...

Shockwave IVL can aid in eliminating recoil and dissection during below-the-knee...

George Adams (Raleigh, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA) about the benefits of using easy-to-use Shockwave IVL (Intravascular Lithotripsy) in calcified...

MedAlliance receives third FDA breakthrough device designation for its sirolimus DEB...

device designation for its sirolimus DEB
MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) breakthrough device designation status for a...

CMS approves coverage for PQ Bypass TORUS 2 IDE trial

Torus stent graft (PQ Bypass)
PQ Bypass announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device...

Cardiovascular Systems introduces peripheral orbital atherectomy system with GlideAssist in Europe

Interventional News for specialists
Cardiovascular Systems announced today that the first patient in Europe has been treated with its Stealth 360 peripheral orbital atherectomy system (OAS) 1.25mm Micro...

IVUS during haemodialysis access “aids device selection and adequacy of treatment”

Narayan Karunanithy outlines the benefits of intravascular ultrasound (IVUS) during haemodialysis access intervention. Thoracic central veins include intra-thoracic segments of the internal jugular, subclavian, brachiocephalic...

Reaction to the Katsanos et al meta-analysis

claims
Internal BIBA MedTech data show that perceptions on paclitaxel devices have shifted considerably in the twelve months that have elapsed since Konstantinos Katsanos (Patras,...

More trained interventionalists needed to treat stroke “on the spot”

trained interventionalists needed to treat stroke on the spot
Nick Hopkins (Buffalo, USA) talks to BLearning Neuro at VEITH Symposium 2018 (13–17 November 2018, New York, USA) about the DAWN trial, which showed that in carefully selected acute...

Benefit and risk: Meta-analysis draws a heterogeneous picture of drug-coated balloon...

Scientists of Jena University Hospital, Germany, conducted a meta-analysis sought to evaluate benefit and risk of paclitaxel-coated balloon angioplasty compared to plain old balloon...

Philips receives FDA approval for low-dose drug-coated balloons

Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...

No evidence of increased mortality with paclitaxel-based devices in German claim...

Interventional News for specialists
A real-world safety analysis of paclitaxel-based devices in peripheral arteries, recently published in the European Heart Journal, showed no evidence for increased mortality over...

Medtronic receives FDA breakthrough device designation for its Valiant Navion LSA...

Medtronic today announced it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Valiant TAAA stent graft system...

Intra-arterial calcification poses “one of the biggest challenges” for endovascular therapy

Andrew Holden (Auckland, New Zealand) provides perspective on the first results from the Disrupt PAD III observational registry that were presented at the Charing...

BD announces publication of drug-coated balloon safety data for femoropopliteal PAD

BD has announced the publication of a company-initiated, independent analysis of the Lutonix 035 drug-coated balloon (DCB) femoropopliteal clinical programme in the Journal of...

TINTIN trial shows “impressive” results at six months

Interventional News for specialists
The six-month results of TINTIN (Treatment with the lumINor DCB and The IVolutioN self-expanding stent) trial have been revealed at the annual meeting of the Cardiovascular and...

LimFlow receives FDA approval for US study of minimally-invasive technology designed...

LimFlow has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the PROMISE II pivotal study of...

Orchestra BioMed announce FDA breakthrough device designation for Virtue sirolimus-eluting balloon

Orchestra BioMed, in partnership with Terumo Corporation, today announced that the company has secured breakthrough device designation by the US Food and Drug Administration...

FDA clears Artis icono family of angiography systems from Siemens Healthineers

The US Food and Drug Administration (FDA) has cleared the Artis icono, a family of angiography systems from Siemens Healthineers that permit a range...

Proximo Medical named commercialisation partner for Biotronik’s PVI portfolio in select...

pulsar
According to a press release, Proximo Medical has been announced as the commercial partner for Biotronik's peripheral vascular intervention (PVI) platform in select US markets.  Proximo Medical is...

Novel paclitaxel-nano-coated balloon achieves lower incidence of restenosis than plain balloon...

  Two-year results of EffPac—a randomised controlled trial to assess the safety and efficacy of a novel drug-coated balloon (DCB) with a nanotechnology coating—have been...

First patient enrolled in Cook Regentec’s clinical trial of investigational therapy...

Cook Regentec has announced enrolment of the first patient in an international clinical trial evaluating the HemaTrate Blood Filtration System to treat patients with...

New Cook Medical paclitaxel data confirm safety of Zilver PTX

New data on the use of Zilver PTX, Cook Medical’s paclitaxel-coated stent for peripheral arterial disease (PAD), confirms the safety of the device. These...

Beacon Tip catheters available in Europe again

Beacon Tip catheters (Cook Medical) are once again available to physicians in Europe. As of September 2019, the catheters are available in the UK,...

MagicTouch AVF sirolimus-coated balloon granted FDA breakthrough device designation

breakthrough
Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for MagicTouch AVF, its sirolimus drug-coated balloon (DCB)...

Surmodics completes enrolment in pivotal TRANSCEND clinical trial

Surmodics logo
According to a press release, Surmodics has completed enrolment in TRANSCEND, its pivotal clinical trial for the SurVeil drug-coated balloon (DCB). “TRANSCEND is a rigorous...

Cardiovascular Systems announces first patient enrolled in REACH PVI clinical study

Interventional News for specialists
Cardiovascular Systems recently announced that the first patient has been enrolled in the REACH PVI study. The purpose of this study is to prospectively...

Endologix announces reinstatement of CE mark for its Nellix endovascular aneurysm...

Nellix aneurysm sealing system
Endologix recently announced that the EC Certificate of Conformity (CE mark) for the Nellix endovascular aneurysm sealing system (Nellix system) has been reinstated by...

Eluvia drug-eluting stent continues to demonstrate positive outcomes in IMPERIAL trial...

Boston Scientific has announced results from sub-analyses of the IMPERIAL clinical trial for the Eluvia Drug-Eluting Vascular Stent System. Data demonstrated that the efficacy...

Canon Medical Systems launches Alphenix interventional imaging line

Canon Medical Systems USA recently introduced its next generation of interventional systems—the Alphenix platform. The new platform of systems incorporates all-new features that enable clinicians...

Gore Tigris vascular stent demonstrates high patency rates at 12 months

New results suggest that the Tigris vascular stent (Gore) is a safe and effective device that can be incorporated into a modern “leave-nothing-behind” treatment...

Vascular Dynamics names Martin Rothman chief medical officer

Martin T Rothman has been appointed as chief medical officer of Vascular Dynamics, effective 1 January 2019. Rothman is a pioneer in interventional cardiology, as...

BELONG study enrols first patients

Enrolment of the first patients in the BELONG study—benefit of arterial vessel preparation by arterial by longitudinal micro-incisions before drug-eluting balloon angioplasty of the...