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Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional 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 a…
Enrollment begins in PERSEVERE clinical trial of hybrid prothesis for aortic dissection
Artivion announced today that it has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis. The trial is designed to…
Cordis announces start of enrollment in RADIANCY clinical study in Europe
Cordis has announced the start of the European RADIANCY premarket clinical study of a stent system designed for radial access in the treatment of peripheral artery disease (PAD). RADIANCY is a prospective, multicenter, single-arm study to assess the safety and…
AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic stenosis treatment
A prospective, multicenter 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 in the Journal…
PAD: Ra Medical Systems receives FDA 510(k) clearance for the Dabra 2.0 catheter
Ra Medical Systems has announced receipt of Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system for the treatment of peripheral arterial disease (PAD). A company press release…
Terumo Aortic announces first commercial implant of Thoraflex Hybrid in US
Following the recent approval by the Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial implant of…
Expanded Medicare coverage for TCAR in standard surgical risk patients announced
Silk Road Medical today announced that the Centers for Medicare and Medicaid Services (CMS), through collaboration with the Society of Vascular Surgery’s Patient Safety Organization (SVS PSO) and their Vascular Quality Initiative (VQI), has expanded coverage for TCAR to include…
FDA grants IDE approval for Selution SLR drug-eluting balloon
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the Food and Drug Administration, making it the first limus DEB to be available to U.S. patients, the company announced in a press release. The Selution…
New long-term data of paclitaxel devices continue to show no increased mortality compared to non-drug coated devices
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (May 19–22) in Atlanta. The analysis…
Venovo venous stent returns to US market after 2021 recall
BD recently announced that its Venovo venous stent is back on the U.S. market following a recall last year. In 2019, the company reported that the Food and Drug Administration (FDA) had granted premarket approval for the Venovo venous stent. In…