Gore Viafort Vascular Stent IVC Study Enrolls First US Patient

March 28, 2023—Gore & Associates announced that the first patient in the United States has been enrolled in the pivotal Gore Viafort Vascular Stent IVC Study, which is evaluating the investigational Gore Viafort vascular stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction.

The device will be studied in a treatment range of 10- to 28-mm diameter for iliofemoral veins and the IVC. The prospective, nonrandomized, multicenter, single-arm study will include 5-year follow-up of enrolled patients.

The first patient in the United States was enrolled by Kush Desai, MD, at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

“It is exciting to have enrolled the first United States patient, an important milestone for venous occlusive disease treatment,” commented Dr. Desai in the company press release. “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 study is being conducted in the United States under an FDA-approved investigational device exemption. Additional centers in Europe, Australia, and New Zealand will also participate in this study. In October 2022, the company announced that the first-in-human implantations of the Viafort vascular stent were performed as part of the study by interventional radiologist Andrew Holden, MD, at the Auckland City Hospital in Auckland, New Zealand.

The Gore Viafort vascular stent utilizes the company’s expanded polytetrafluoroethylene technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The Viafort stent, which is limited to investigation use by United States law, has received Breakthrough Device designation from the FDA, advised the company.