W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with five-year follow-up (NCT05489588) to evaluate the investigational GORE® VIAFORT Vascular Stent for the treatment of symptomatic iliofemoral venous obstruction.
The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, 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. 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 utilizes 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 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption (IDE).
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives.
CAUTION: Investigational device. Limited by United States law to investigational use.
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