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FDA approves study of ZFEN+ for treatment of aortic aneurysms
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+). The clinical study will assess the safety and effectiveness of the ZFEN+ in…
Getting medical devices to market: The future might not be now, says regulatory expert
The development of medical devices in the vascular space faces increasing challenges amid moves afoot at the Food and Drug Administration (FDA), according to a leading regulatory expert in the field. Among the developmental vehicles currently caught in the crosshairs…
First US patient enrolled in Gore Viafort vascular stent pivotal study
W L Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, randomized, multicenter, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic inferior…
How a multidisciplinary team meets the complex challenges of fixing failed EVARs
This advertorial is sponsored by Tampa General Hospital. The Aortic Disease Program at Tampa General Hospital’s Heart & Vascular Institute is no stranger to the challenges of complex care. Situated in the population center of Tampa, Florida, in the nation’s…
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…
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…
First patient enrolled in Wrapsody endoprosthesis registry study
Merit Medical has announced the successful enrollment of the first patient in its WRAP registry study in a press release. The study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving hemodialysis…
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…
Complex TAAA: US ARC IDE registry reports better survival vs. real-world data after endovascular repair
Patients treated in Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials for complex thoracoabdominal aortic aneurysms (TAAAs) in the U.S. Aortic Research Consortium (ARC) had better 30-day and one-year survival compared with those recorded in the real-world Vascular…
The top 10 most popular Vascular Specialist stories in January
January’s top 10 includes “Our forever plague,” a combined editorial by Malachi Sheahan III, MD, our medical editor, on fake news and science, and coverage of the U.S. investigational device exemption (IDE) Aortic Research Consortium and how the chief investigators…