Tag: BTK
Cordis announces positive 24-month results from Selution SFA Japan trial
Cordis has announced positive 24-month results from the Selution SFA Japan trial. The prospective, multicentre, single-arm trial is designed to assess the safety and...
US FDA Breakthrough Device designation granted for DynamX BTK for use...
Elixir Medical has announced Breakthrough Device designation by the US Food and Drug Administration (FDA) for its novel DynamX BTK System, an implant for...
Summa Therapeutics announce first-in-man injectable angioplasty treatments for PAD
Summa Therapeutics has announced that the first-in-man injectable angioplasty procedures for patients with below-knee peripheral arterial disease (PAD) were performed successfully using its Finesse...
“First victory” in BTK space demonstrates lessons learned and paves the...
Lawrence Garcia (St Francis Hospital, New York, USA) speaks to Vascular News at VIVA 2023 (30 October–2 November, Las Vegas, USA) on lessons learned...
RECOIL study: Serranator demonstrates 49% less recoil than plain balloon angioplasty...
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...
Concept Medical granted IDE approval for Magic Touch sirolimus DCB below...
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...
PRELUDE-BTK subanalysis highlights superior lumen gain, greater volumetric blood flow using...
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...
SAVAL trial finds no gains with custom drug-eluting stents in PAD...
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...
Selution SLR receives second FDA IDE approval
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...
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...
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...
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...
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...
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...
FDA advisory panel recommends against premarket approval of Lutonix 014 DCB...
A US Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in...
Study shows those with in-tack restenosis have shorter lesions than those...
Raghu Kolluri (Columbus, USA) talks to Vascular News about a recent comparative study looking at differences between in-tack and in-stent restenosis. The study examined...
LINC 2021: Novel approaches and new data for BTK interventions revealed
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the...
Combination of scaffold and drug in BTK intervention “without question” the...
Sahil Parikh (New York, USA) talks to Brian DeRubertis (Los Angeles, USA) at VEITHsymposium 2019 (19–23 November, New York, USA) about the future of below-the-knee...
OUTBACK™ Elite Re-entry catheter highly effective at saving limbs in extreme...
Lorenzo Patrone (London, UK) shares with BLearning at CIRSE 2019 (7–11 September, Barcelona, Spain) the benefits of using the OUTBACK™ Elite Re-entry Catheter (Cordis,...
Lutonix BTK IDE: First Level 1 evidence of positive safety and...
Patrick Geraghty (St Louis, USA) presented new datapoints from the six-month outcomes of the Lutonix BTK IDE trial at the 2018 VEITHsymposium (13–17 November,...
SAVAL trial of new below-the-knee drug-eluting stent begins
The first patient has been enrolled in the SAVAL pivotal trial to evaluate clinical outcomes of the SAVAL below-the-knee (BTK) drug-eluting stent system (Boston...
First-ever CE mark of a bioresorbable scaffold for below-the-knee PAD
Reva Medical, a company developing bioresorbable polymer technologies for vascular applications, has announced that its Motiv bioresorbable scaffold is the first drug-eluting bioresorbable scaffold...
