Tag: IDE

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...

AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic...

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...

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...

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...

Complex TAAA: US ARC IDE registry reports better survival vs. real-world...

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...

Vascular Specialist–February 2022

In this issue: "Vital signs": Reporting from the Southern Association for Vascular Surgery (SAVS) annual meeting on skyrocketing nursing costs and their contribution to...
top 10 vascular specialist

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...

Thrombolex: Investigational RESCUE trial yields ‘exciting’ interim data

The prespecified interim analysis of the first 62 evaluable pulmonary embolism (PE) patients enrolled in the investigational RESCUE trial produced positive results, Thrombolex has...

US IDE Aortic Research Consortium ‘pushes the envelope’ on F/BEVAR

The U.S. investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair...

Endologix announces completion of enrollment in TORUS 2 study for PAD...

Endologix has completed enrollment in the TORUS 2 investigational device exemption (IDE) clinical study in the U.S., a press release reports. The TORUS 2 study...

VenoValve: Chronic venous insufficiency device gains brisk double of first US...

Hancock Jaffe Laboratories recently revealed that the United States Patent and Trademark Office (USPTO) issued the first patent covering the company’s VenoValve. The patent is...

Treo IDE primary endpoint results announced

In the wake of approval by the Food and Drug Administration (FDA) of the Treo abdominal aortic stent-graft system for the treatment of patients...

FDA grants Nexus aortic arch stent graft system breakthrough designation

Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough...

Aortic neck dilation after FEVAR leads to little clinical impact, new...

MIAMI—Data, gathered in a study on the impact of aortic neck dilation after fenestrated endovascular aortic aneurysm repair (FEVAR), show that the process does...