Tag: CLTI

Selution

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...
reintervention

Researchers report higher three-year amputation and reintervention rates in Black and...

In a study of over 7,000 chronic limb-threatening ischaemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention...

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...
BTK

Revascularisation strategy for BTK intervention should hinge on diagnostic modality, LINC...

New data provide “another argument” for the use of intravascular ultrasound (IVUS) in below-the-knee (BTK) interventions. This is according to Michael Lichtenberg (Arnsberg Vascular...

Non-optimal therapy for CLTI “more prominent in females”

A real-world claims data analysis of nearly 200,000 patients with chronic limb-threatening ischaemia (CLTI) showed that female patients were older, underwent vascular procedures less...

SCAI releases multi-society position statement focused on core competencies for endovascular...

The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement outlining competencies for endovascular specialists who provide care for chronic limb-threatening...
LimFlow stent provides CLTI Patients relief

LimFlow raises US$40 million 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 US 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 (LimFlow SA) designed to prevent amputations in...

CX 2022 highlights new data in the vascular world

Anticipation is building for the Charing Cross International Symposium 2022 (26–28 April, London, UK, in person and virtual), which this year will address some...
popular

Vascular News’ top 10 most popular stories of January 2022

Breakthrough designation for a new drug-eluting stent from Cook Medical, a meta-analysis on the safety of expedited carotid artery surgery vs. expedited stenting after...
vascular trauma

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...
IVL

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...
popular

Vascular News’ top 10 most popular stories of October 2021

New data from a head-to-head, randomised trial comparing vascular closure devices, highlights from CX Aortic Vienna 2021 (5–7 October, broadcast) and an interview with past Society...
XO Cross

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...
Peter Schneider bypass

Surgeons must stay skilled in femorotibial/pedal bypass surgery, PVI audience hears

At Paris Vascular Insights (PVI) 2021 (21–23 October, Paris, France), Peter Schneider (University of California San Francisco, San Francisco, USA) emphasised the need for...
amputation

Study supports use of WIfI classification system to predict revascularisation benefit...

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

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...
MedAlliance SELUTION SLR

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...
popular

Vascular News’ top 10 most popular stories of June 2021

New data from Philips' TOBA II below-the-knee (BTK) clinical trial, physicians' call for the AMPREDICT decision support tool to be applied in clinical practice,...

Lack of access to vascular specialists creates major disparities in amputation...

Speaking on current trends in amputation rates with critical limb-threatening ischaemia (CLTI) patients, Misty Humphries (Sacramento, USA) tells Vascular News that while Medicare data shows that amputation rates...

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 with...
popular

Vascular News’ top 10 most popular stories of May 2021

Expanding eligibility for endovascular aneurysm repair (EVAR), new tools for chronic limb-threatening ischaemia (CLTI), and promising data for arteriovenous (AV) fistula remote monitoring all...

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)....
LimFlow stent provides CLTI Patients relief

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...
CLTI

New tools for CLTI: ISET audience hear what’s on the horizon...

“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....
journal

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...
breakthrough

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)...

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...

“On the descending curve”: BEST-CLI rises to COVID-19 and financial challenges

Vascular News spoke to the principal investigators of the BEST-CLI (Best endovascular versus best surgical therapy in critical limb ischaemia) trial—Alik Farber (Boston Medical...
Rexgenero

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...
COVID-19

Letter from Seattle: Amid COVID-19 pandemic, time to act is long...

Amid the COVID-19 pandemic, Benjamin W Starnes and Niten Singh urge service chiefs across the USA to "act this minute" in order to conserve...

Interdisciplinary wound care teams are integral for CLTI patients’ care, ISET...

The 32nd International Symposium on Endovascular Therapy (ISET; 22–25 January, Hollywood, USA) had a particular focus on treating critical limb-threatening ischaemia (CLTI). In the...
Ramon Varcoe

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...

Vascular surgeons and cardiologists respond to new meta-analysis of PCBs in...

Eminent vascular surgeons and interventional cardiologists including Kim Hodgson (Springfield, USA), Ramon Varcoe (Sydney, Australia) and Gary Ansel (Columbus, USA) give their thoughts on...

IR experts respond to new meta-analysis of paclitaxel-coated balloons in infrapopliteal...

 A range of interventional radiology experts including Michael Dake (Tucson, USA), John Kaufman (Portland, USA), Jim Reekers (Amsterdam, The Netherlands) and Gunnar Tepe (Rosenheim,...
vascular limb salvage clinic

Vascular limb salvage (VaLS) clinic helps to meet the VSGBI time-to-treatment...

Described as “deliberately challenging”, the new time-to-treatment targets published by the Vascular Society of Great Britain and Ireland (VSGBI), as part of the Peripheral...
LimFlow stent provides CLTI Patients relief

First CLTI patient enrolled in PROMISE II pivotal study of LimFlow...

LimFlow, a specialist in minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), has announced...
limflow stent

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...

New Global Vascular Guidelines for CLTI patients now open for stakeholder...

 The draft Global Vascular Guidelines on chronic limb threatening ischaemia (CLTI) have just been posted for open public comment until 3 December 2018. Michael...