W L Gore and Associates (Gore) has enrolled the first US patient in its study for the assessment of its investigational Gore VIAFORT Vascular Stent to treat symptomatic iliofemoral venous obstruction.
The subject was enrolled by Dr David Dexter II at Sentara Vascular Specialists healthcare facility in Norfolk, Virginia.
The multi-centre, non-randomised, prospective single-arm study is being carried out in the US and comes with a five-year follow-up.
Dexter said: “With several 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.”
The clinical trial is focused on assessing the device in a 10mm to 20mm diameter treatment range for iliofemoral veins.
The device leverages the Gore expanded polytetrafluoroethylene technology, along with a single-wire, sinusoidal-wound nitinol frame.
Founded in 1958, Gore is involved in the development of medical devices to treat various cardiovascular and other health conditions.
In February this year, Gore announced the start of its EMBRACE Registry to evaluate the safety and clinical performance of the VBX stent graft for use as a bridging stent with a branched/fenestrated stent graft to treat aortic aneurysms involving the renal-mesenteric arteries.
