Gore’s Viafort Vascular Stent Being Evaluated in Pivotal Study for the Treatment of IVC Occlusive Disease

October 28, 2022—Gore & Associates announced the first-in-human implantations of the company’s investigational Viafort vascular stent were performed as part of the recently initiated GORE VIAFORT Vascular Stent Inferior Vena Cava (IVC) pivotal study.

According to the company, the study is a prospective, multicenter, nonrandomized, single-arm evaluation of the treatment of IVC occlusive disease with or without iliofemoral vein involvement using the Viafort in a treatment range of 10- to 28-mm diameter for iliofemoral veins and the IVC. The study is being conducted in the United States under an investigational device exemption. Additional centers in Europe, Australia, and New Zealand will also participate in this study.

The Viafort vascular stent, which has received Breakthrough Device designation from the FDA, uses Gore’s expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wound nitinol frame.

The first patient procedure was completed by interventional radiologist Andrew Holden, MD, at the Auckland City Hospital in Auckland, New Zealand. Dr. Holden is Director of Regional Interventional Radiology at the Auckland Regional Public Health Service.

"This first implantation is an important milestone for venous occlusive disease treatment," commented Dr. Holden in Gore's press release. “Right now, there are limited device options indicated for both IVC and iliofemoral venous disease. Implanting the Gore Viafort vascular stent in patients represents a significant step forward in research.”