W. L. Gore & Associates has received approval from the U.S. Food and Drug Administration (FDA) for its GORE VIABAHN FORTEGRA Venous Stent, marking it as the first device indicated for treating deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins.
The newly approved stent is designed to address the needs of patients with deep venous disease. It features an open-structure, self-expanding wire-wound nitinol frame combined with an expanded polytetrafluoroethylene (ePTFE) polymer lattice. According to Gore, this design aims to balance conformability with strength and resistance to fracture.
"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, iliac veins and inflow femoral veins. Patients will benefit from a device that is designed specifically for this disease and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through iliocaval confluence and side branch preservation,” said Kush Desai, MD, National Primary Investigator.
The FDA granted Breakthrough Device designation to the FORTEGRA Venous Stent, which accelerated its development and review process due to its potential to offer more effective treatment options for serious or debilitating conditions.
An international clinical trial evaluated the safety and effectiveness of the device in 89 patients suffering from deep venous disease. The study population included individuals with significant disease burden: all participants were treated for thrombotic disease—ranging from acute and subacute cases to post-thrombotic syndrome—with most having lesions spanning three vessel regions (IVC plus bilateral iliofemoral veins). A majority required stents extending below the inguinal ligament into the common femoral vein.
Despite these challenging cases, results showed that 83.4% of patients achieved primary patency at 12 months. The data also indicated primary patency rates of 96.5% in the IVC region, 88.9% in left iliofemoral vessels, and 89.8% in right iliofemoral vessels after one year. No incidents of stent embolization or migration, fractures, vascular injuries, or clinically significant pulmonary embolisms were reported during this period. There were no device-related deaths or major bleeding events within 30 days following implantation. The study met its composite efficacy and safety endpoint at 12 months.
The company states that over its five-decade history it has implanted more than 55 million medical devices globally.
The GORE VIABAHN FORTEGRA Venous Stent is intended for use in treating symptomatic IVC obstruction with or without combined iliofemoral obstruction in U.S. patients. However, it is contraindicated for use where angioplasty balloon expansion does not meet minimum recommended vessel diameters during pre-dilatation or when lesions cannot be sufficiently dilated to allow passage of the delivery system.
For full indications and important safety information regarding Gore’s commercial products mentioned here, refer to their Instructions for Use.
