Gore has announced that the first US patient has been enrolled in a prospective, non-randomised, multicentre, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic iliofemoral venous obstruction.
The first US patient was enrolled by David J Dexter II at Sentara Vascular Specialists, Norfolk, USA. “With several US Food and Drug Administration [FDA]-approved stents on the market, there was a concern that enrolment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the Viafort device is compelling to use in a clinical trial,” he said.
A company press release notes that the Gore Viafort vascular stent utilises the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The Gore Viafort vascular stent iliofemoral study is evaluating the device in a treatment range of 10 to 20mm diameter for iliofemoral veins. The study is being conducted in the USA under an approved investigational device exemption (IDE).