W L Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, randomized, multicenter, single-arm study with five-year follow-up 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 US patient was enrolled by Kush Desai, MD, at Northwestern University Feinberg School of Medicine in Chicago. “It is exciting to have enrolled the first US patient, an important milestone for venous occlusive disease treatment,” stated 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 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 10–28mm diameter for iliofemoral veins and the IVC. The study is being conducted in the U.S. under an approved investigational device exemption (IDE).