Gore gains FDA approval for first deep venous stent indicated for the IVC and iliofemoral veins

May 7, 2026
Source: ASM International

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W. L. Gore & Associates, Newark, Delaware, announced on January 6, 2026 that the U.S. Food and Drug Administration has approved the GORE VIABAHN FORTEGRA Venous Stent for the treatment of deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins. The device is the first stent approved in the United States for the IVC and iliofemoral indication, and previously received FDA Breakthrough Device designation.

The FORTEGRA Venous Stent (formerly the GORE VIAFORT Vascular Stent) consists of an open-structure, self-expanding wire-wound nitinol frame and an expanded polytetrafluoroethylene (ePTFE) polymer lattice. The combination is designed to balance conformability to the natural venous anatomy with compression resistance throughout the entire device length, while the wound nitinol architecture supports fracture resistance under the dynamic mechanical loading characteristic of large-vein anatomy.

Approval was supported by an international pivotal trial that evaluated 89 patients with deep venous disease across the IVC, iliac, and iliofemoral veins. The device met its primary safety and effectiveness endpoints and demonstrated patency, freedom from clinically driven reintervention, and safety performance consistent with a first-line venous stent indication.

W. L. Gore & Associates is a privately held global manufacturing company founded in 1958 and headquartered in Newark, Delaware. Its medical products division supplies cardiovascular, vascular, structural heart, and surgical solutions in more than 50 countries and has served the deep venous disease space through prior peripheral and arteriovenous platforms.

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