Gore’s Viabahn Fortegra Venous Stent Gains CE Mark

W.L. Gore & Associates (Gore) has received CE mark approval for its Viabahn Fortegra venous stent, which is indicated to treat symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction.

The Fortegra venous stent, specifically designed to treat patients with deep venous disease, is the newest addition to the Viabahn device family. It consists of an open-structure, self-expanding, wire-wound nitinol frame and a polymer lattice, which is engineered for conformability, strength, and fracture resistance.

Gore said the tech helps provide a balance and combination of allowing the stent to conform to natural anatomy while offering compression resistance throughout the whole devices. The Fortegra venous stent is appropriate for a wide range of anatomies, Gore said, because it’s available in a wide range of sizes.

The stent received U.S. Food and Drug Administration (FDA) approval in January of this year. It was also evaluated in a prospective trial, the first of its kind to include the IVC, iliac, and iliofemoral veins.

For patients experiencing pain at baseline, 81% showed improvement in pain at 12 months, with medical reduction in the pain score of -2.0 (p<0.001). Improvements were shown in quality-of-life measures (VEINES-QOL, EQ-5D-5L), and also seen in clinical severity measures, including edema and ulcer-related outcomes. Primary patency remained high at 12 months (83.4% overall), with no device-related safety concerns observed.

“The FORTEGRA Venous Stent represents a significant advancement in the treatment of patients with the most difficult-to-treat venous obstructive pathology; occlusion of the inferior vena cava and iliac veins,” said said Prof. Stephen Black, professor of Venous Surgery at Guy’s and St Thomas’ Hospital London and global primary investigator. “Patients will benefit from a device that is specifically designed for this pathology and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through reconstruction of the iliocaval confluence and the unique properties of physiological movement in the inferior vena cava.”