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June 6, 2023
Gore Commences Pivotal VIAFORT Vascular Stent Iliofemoral Study
June 6, 2023—Gore & Associates announced that the first United States patient has been enrolled in a prospective nonrandomized multicenter single-arm pivotal study with 5-year follow-up to evaluate the Viafort vascular stent for the treatment of symptomatic iliofemoral venous obstruction.
The Viafort device utilizes Gore’s expanded polytetrafluoroethylene technology with a single-wire, sinusoidal-wound nitinol frame. Viafort is an investigational device limited by United States law to investigational use.
According to the company, the GORE VIAFORT Vascular Stent Iliofemoral Study is evaluating the device in a treatment range of 10- to 20-mm diameter for iliofemoral veins. The study is being conducted in the United States under an approved investigational device exemption.
The first patient in the study was enrolled by David J. Dexter II, MD, at Sentara Vascular Specialists in Norfolk, Virginia.
“With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult,” commented Dr. Dexter in Gore’s press release. “Designed with the unique qualities for flexibility and radial force, the Viafort device is compelling to use in a clinical trial.”
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