Tag: CLTI
New data and heated debates set to spark controversy in CX...
“These will be important, salutary lessons. Should a controversy arise again involving a proven efficacious therapy, we now know that stopping access to that...
Endovascular showdown: CX 2024 sets the stage for BASIL-3 first-time data...
At the Charing Cross (CX) Symposium 2024 (23–25 April, London, UK), Andrew Bradbury (University of Birmingham, Birmingham, UK) and the BASIL-3 team of triallists...
US FDA Breakthrough Device designation granted for Biotronik’s Freesolve BTK resorbable...
Biotronik has been granted Breakthrough Device designation (BDD) from the US Food and Drug Administration (FDA) for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold...
Late-breaking analysis set to expose the ‘why and how’ of endovascular...
Set to be presented at the upcoming Society of Interventional Radiology (SIR) annual scientific meeting (23–28 March, Salt Lake City, USA), an anticipated late-breaking...
Efemoral Medical granted Breakthrough Device designation
Efemoral Medical today announced that the US Food and Drug Administration (FDA) has granted its novel Efemoral vascular scaffold system (EVSS) Breakthrough Device status...
UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for...
Following a review, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such...
Low-income patients found to receive low-intensity care for CLTI, associated with...
A recent study published in Circulation concerning patients with chronic limb-threatening ischemia (CLTI) in the USA, has found that patients of low-income status and...
Full cohort results confirms efficacy of Luminor drug-coated balloon for BTK...
iVascular reflect on the Luminor drug-coated balloon (DCB) in below-the-knee (BTK) outcomes obtained in the BIBLIOS trial one-year follow-up presented at the Paris Vascular...
Micro Medical Solutions completes enrolment for STAND MicroStent trial
Micro Medical Solutions (MMS), an innovator in the field of microvascular intervention to improve clinical outcomes and quality of life in patients with chronic...
Inari Medical completes LimFlow acquisition for CLTI treatment
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...
Two-year SWING data “continue to show promise” for sirolimus DCB in...
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...
Revascularisation considered over amputation for CLTI in UK, new study states
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...
LimFlow announces agreement to be acquired by Inari Medical
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...
TCT 2023: LIFE-BTK breathes life into drug-eluting resorbable scaffolds in breakthrough...
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...
Interventional News’ top 10 most popular stories of September 2023
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...
“Excellent” 24-month MOTIV BTK outcomes for bioresorbable scaffold use in below-the-knee...
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...
12-month PRISTINE registry data show efficacy of sirolimus-eluting balloon in the...
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...
US FDA approves LimFlow system for treatment of chronic limb-threatening ischemia
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...
‘Connect the world’ session at LINC 2023 projects “outstanding” first-release data...
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...
Urban residents have smaller risk of mortality from chronic limb-threatening ischaemia
A new study using data from millions of patients hospitalised across the USA has determined whether population density and associated urban versus suburban versus...
Insights from largest chronic limb-threatening ischaemia study to inform quality of...
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...
New analysis of chronic limb-threatening ischaemia patients places BEST-CLI trial into...
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 &...
BASIL-2 points towards endovascular-first revascularisation strategy in CLTI patients
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to...
ESRD strongly associated with adverse limb events in new study
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...
Results from PROMISE II pivotal trial published, reinforcing “transformational value” of...
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...
CX 2023 highlight: The BASIL-2 trial
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,...
Cost effectiveness of urea-based DCB treatment for CLTI patients “extremely important”
A range of experts, including Koen Deloose (Dendermonde, Belgium), Thomas Zeller (Bad Krozingen, Germany), Marianne Brodmann (Graz, Austria) and Antonio Micari (Messina, Italy), talk...
SWING trial 12-month data: Novel sirolimus DCB shows “great promise” in...
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...
First data from BEST-CLI bring surgical bypass into the forefront of...
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)...
First US patient enrolled in Selution SLR IDE peripheral study
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...
First patients enrolled in LIMES randomised trial of Magic Touch sirolimus-coated...
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...
Philips announces positive three-year clinical research results from its TOBA II...
Royal Philips today announced the latest results from the Tack optimised balloon angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular...
LimFlow raises US$40 millions in Series D financing
LimFlow recently announced it has closed a US$40 million (€36 million) oversubscribed Series D financing round.
A press release reports that new investors Longitude...
PROMISE II U.S. pivotal trial of device designed for ‘no-option’ CLTI...
Enrolment has been completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialisation system designed to prevent amputations in so-called "no-option"...
Humacyte’s Human Acellular Vessel for limb salvage evaluated in multiple complex...
Humacyte today announced results from the first series of compassionate use cases of the company’s investigational Human Acellular Vessel (HAV) for the treatment of...
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee...
Novel system-wide interdisciplinary team diverts patients from amputation and improves outcomes
Findings from a first-of-its-kind study conducted at University Hospitals (UH) Harrington Heart & Vascular Institute (Cleveland, USA) showed a novel system-wide interdisciplinary team assembled...
Cordis names George Adams as chief medical officer
Cordis has announced George Adams as chief medical officer.
"We are delighted to have Dr Adams join our team as we continue to build the...
Shockwave Medical enrols first patient in Disrupt BTK II study for...
Shockwave Medical has announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness and optimal clinical use of the...
FDA clears 12 new XO Cross microcatheters
Transit Scientific has announced US Food and Drug Administration (FDA) clearance of new hydrophilic-coated XO Cross microcatheters for guidewire support, exchange, and contrast media...
Study shows risk of major amputation in diabetics with CLTI
A retrospective study supports the use of the Wound, ischaemia, and foot infection (WIfI) classification system to predict the revascularisation benefit for diabetic patients...
VIVA 2021: IVL “consistently” treats real-world calcium in multiple peripheral vessel...
An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL; Shockwave Medical) performs “consistently well” across challenging peripheral vessels,...
Why Rotarex is my first choice treatment in patients with bypass...
NOTE: This video is ONLY available to watch in selected countries and geographies
Bruno Migliara (Peschiera del Garda, Italy) talks to Vascular News about the reasons...
R3 Vascular reports the initiation of its first-in-human clinical study
R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable...
PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrolment
MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of...
Physicians call for clinical application of “helpful, meaningful” AMPREDICT decision support...
Researchers have found that the AMPREDICT decision support tool (DST) demonstrates “strong usability characteristics and clinical relevance” in amputation level decision making for patients...
SoundBite Medical announces use of its Active Wire 0.014″ platform at...
SoundBite Medical Solutions recently announced the use of its novel Active Wire 0.014” platform at a first site in the USA in the successful...
XO Score scoring sheath platform wins medical design award
Transit Scientific today announced that its XO Score scoring sheath platform has been named a winner in the 2021 Medical Design Excellence Awards (MDEA)....
One-year outcomes from PROMISE I US study of LimFlow system published
LimFlow SA recently announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep...
New tools on the horizon for CLTI patients revealed at ISET...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular...
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent....
“A reliable tool”: Positive findings for 2D perfusion angiography in CLTI...
Researchers suggest that, in patients with chronic limb-threatening ischaemia (CLTI), two-dimensional (2D) perfusion angiography is a “reliable tool” when used according to standardised methods....
Introduction of dedicated vascular limb salvage clinic improves one-year amputation outcomes...
One-year outcomes of patients with chronic-limb threatening ischaemia (CLTI) treated in an outpatient-based vascular limb salvage clinic show an improved rate of major amputation....
The CLI Global Society announces the Journal of Critical Limb Ischemia
The CLI Global Society is launching the first peer-reviewed academic journal focusing on interventional techniques pertaining to critical limb ischemia (CLI). The new journal,...
Real-world data on SeQuent Please OTW DCB presented at LINC 2021
One-year findings of the CONSEQUENT all-comers observational study of the paclitaxel drug-coated balloon (DCB) SeQuent Please OTW (B Braun) were reported at LINC 2021...
FDA grants breakthrough device designation to PEDRA Xauron real-time tissue perfusion...
The US Food and Drug Administration (FDA) has granted Pedra Technology a breakthrough device designation for the periprocedural use of the company’s Pedra Xauron...
No safety concerns and favourable patency at two years with Absorb...
The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) can be used for the treatment of chronic limb-threatening ischaemia (CLTI) patients in infrapopliteal arteries with...
CDC recognises and codifies critical limb-threatening ischaemia in ICD-10-CM
A coalition organised by the CLI Global Society has announced its proposal to distinctly recognise "critical limb ischaemia" (CLI) and "chronic limb-threatening ischaemia" (CLTI)...
Deep vein arterialisation should be considered in “no option” CLTI patients,...
Midterm results from a study of the largest population of patients with no-option chronic limb-threatening ischaemia (CLTI) treated with percutaneous deep vein arterialisation (pDVA)...
Systematic review and meta-analysis finds “substantial” one-year mortality rate in octogenarians...
In octogenarians with chronic limb-threatening ischaemia (CLTI), researchers found a one-year mortality rate of 32% after revascularisation, which was significantly higher than in non-octogenarians....
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...
Rexgenero acquires the key technology and programme assets of aratinga.bio SAS...
Rexgenero, a regenerative medicine company developing advanced cell therapies to treat chronic limb-threatening ischaemia (CLTI), has announced the acquisition of all the key assets...
Pedal artery revascularisation: Is it ready for prime time?
Reviewing the available evidence for below-the-ankle interventions in the treatment of critical limb-threatening ischaemia (CLTI), Srini Tummala proposes that pedal artery intervention “should be...
Veterans study suggests surgery is still dominant revascularisation approach for critical...
A review of data from Veteran Health Administration shows that there was a temporal increase in the use of revascularisations for the management of...
New meta-analysis finds “no observed difference” in mortality between paclitaxel and...
February 2020 brings another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et...
IR experts respond to new meta-analysis of paclitaxel-coated balloons in infrapopliteal...
A range of interventional radiologists experts including Michael Dake (Tucson, USA), John Kaufman (Portland, USA), Jim Reekers (Amsterdam, The Netherlands) and Gunnar Tepe (Rosenheim,...
Vascular surgeons and cardiologists respond to new meta-analysis of PCBs in...
Vascular and interventional cardiology experts including Kim Hodgson (Springfield, USA), Ramon Varcoe (Sydney, Australia) and Gary Ansel (Columbus, USA) give their thoughts on the...
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...
