Gore aims to evaluate Viafort for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without iliofemoral obstruction.
The prospective, non-randomized, multi-center, single-arm study includes five-year follow-up. Dr. Kush Desai of Northwestern University Feinberg School of Medicine enrolled the first U.S. patient.
“It is exciting to have enrolled the first U.S. patient, an important milestone for venous occlusive disease treatment,” said 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.”
Gore’s Viafort stent features expanded polytetrafluoroethylene (ePTFE) technology. It works in conjunction with a single-wire, sinusoidal-wound nitinol frame. The system holds FDA breakthrough device designation.
According to Gore, the study evaluates Viafort in a treatment range 10–28 mm diameter for iliofemoral veins and the IVC. The company is conducting the study in the U.S. under FDA investigational device exemption (IDE).
