FIRST U.S. PATIENT ENROLLED IN GORE VIAFORT Vascular Stent pivotal study
Investigational GORE VIAFORT Vascular Stent. (Credit: PR Newswire/ W. L. Gore & Associates, Inc. MPD Division)
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 5-year follow-up (NCT05409976) to evaluate the investigational GORE VIAFORT Vascular Stent for the Treatment of Symptomatic Inferior Vena Cava (IVC) Obstruction with or without combined Iliofemoral Obstruction.
The first U.S. patient was enrolled by Kush Desai, M.D. at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “It is exciting to have enrolled the first U.S. patient, an important milestone for venous occlusive disease treatment,” stated Dr. Desai. “With no device options indicated, or frankly designed for both IVC and iliofemoral venous disease, implanting the GORE VIAFORT Vascular Stent in patients represents a significant step forward in research and ultimately management of these complex patients.”
A company press release notes that the GORE VIAFORT Vascular Stent, which has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The Gore VIAFORT Vascular Stent IVC study is evaluating the device in a treatment range of 10–28 mm diameter for iliofemoral veins and the IVC. 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 50 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.
Source: Company Press Release