W.L. Gore and Associates (Gore) announced the first U.S. patient was enrolled in a prospective, non-randomized, multicenter, single-arm study with five-year follow-up to assess the investigational GORE VIAFORT vascular stent to treat symptomatic iliofemoral venous obstruction.
 
The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Va. “With several FDA-approved stents on the market, there was a concern that enrollment 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 told the press.
 
The VIAFORT vascular stent uses Gore’s expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The study is evaluating the device in a treatment range of 10 to 20 mm diabetes for iliofemoral veins. The study is being conducted under an approved investigational device exemption (IDE).