Gore Viabahn Fortegra Venous Stent Receives CE Mark Approval Under EU MDR

June 9, 2026—Gore & Associates announced CE Mark approval for its Viabahn Fortegra venous stent, indicated for use in the treatment of symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction. The approval is granted under the European Union Medical Device Regulation. The company announced FDA approval of the device in January 2026.

According to the company, the Viabahn Fortegra venous stent is specifically engineered to treat patients with deep venous disease. It consists of an open-structure, self-expanding, wire-wound nitinol frame and a polymer lattice to provide conformability, strength, and fracture resistance.  Additionally, the technology allows the stent to conform to the natural anatomy while providing compression resistance throughout the entire device.

The Viabahn Fortegra device features a wide range of sizes and is appropriate for a wide range of patient anatomies, noted Gore.

The company stated that results from a prospective trial evaluating the Fortegra venous stent that included the IVC, iliac, and iliofemoral veins demonstrated the device to be safe and effective for its indicated use in patients with deep venous disease.

In the press release, Gore summarized the findings as follows:

• Among patients who experienced pain at baseline, 81% showed improvement in pain at 12 months, with a median reduction in the pain score of -2.0 (P < .001).
• Significant improvements were demonstrated across validated quality-of-life measures (VEINES-QOL, EQ-5D-5L).
• Improvements were observed 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 trial’s Global Primary Investigator is Professor Stephen Black, MD, Professor of Venous Surgery at Guy’s and St Thomas’ Hospital in London, United Kingdom.

“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 IVC and iliac veins,” commented Prof. Black in Gore’s press release. “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 IVC.”

Professor Gerry O’Sullivan, MD, an interventional radiologist at University Hospital Galway in Galway, Ireland, added, “What is particularly important about this evidence is that it reflects the full thrombotic spectrum we treat in practice—acute, subacute, and post-thrombotic syndrome.”

Prof. O’Sullivan continued, “This prospective study demonstrated conclusively that patients benefitted from a device that is specifically designed for patients with complex cases involving the IVC, iliac veins, and inflow veins. Results showed clinically meaningful benefits, alongside improvements in patient quality of life and clinical severity measures.”