Sam Brusco, Associate Editor03.28.23
W.L. Gore & Associates (Gore) announced that the first U.S. patient was enrolled in its prospective, non-randomized, multicenter, single-arm study with five-year follow-up to assess its investigational GORE VIAFORT vascular stent to treat symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction.
The first patient was enrolled by Kush Desai, M.D. at the Northwestern University Feinberg School of Medicine in Chicago, Ill.
"It is exciting to have enrolled the first U.S. patient, an important milestone for venous occlusive disease treatment," Dr. Desai told the press. "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."
The GORE VIAFORT vascular stent received breakthrough status from the U.S. Food and Drug Administration (FDA). Its first implantations took place in November 2022.
The vascular stent uses Gore’s expanded polytetrafluoroethylene (PTFE) tech in conjunction with a single wire, sinusoidal-wound nitinol frame. The IVC study is evaluating the VIAFORT stent 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 and approved investigational device exemption (IDE).
The first patient was enrolled by Kush Desai, M.D. at the Northwestern University Feinberg School of Medicine in Chicago, Ill.
"It is exciting to have enrolled the first U.S. patient, an important milestone for venous occlusive disease treatment," Dr. Desai told the press. "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."
The GORE VIAFORT vascular stent received breakthrough status from the U.S. Food and Drug Administration (FDA). Its first implantations took place in November 2022.
The vascular stent uses Gore’s expanded polytetrafluoroethylene (PTFE) tech in conjunction with a single wire, sinusoidal-wound nitinol frame. The IVC study is evaluating the VIAFORT stent 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 and approved investigational device exemption (IDE).