W.L. Gore & Associates (Gore) has earned U.S. Food and Drug Administration (FDA) approval for its Viabahn Fortegra venous stent (previously known as the Viafort vascular stent) to treat deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins.

The Fortegra venous stent was engineered to treat patients with deep venous disease. It’s composed of an open-structure, self-expanding, wire-wound nitinol frame and expanded polytetrafluoroethylene (ePTFE) polymer lattice, designed for conformability, strength, and fracture resistance.

Gore said the technology helps provide an optimal balance and combination of allowing the stent to conform to the natural anatomy while offering compression resistance throughout the entire device. The Fortegra stent comes in a wide range of sizes and is appropriate for a wide variety of patient anatomies, the company also said.

“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, said Kush Desai, MD, and National Primary Investigator. “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,” says Kush Desai, MD, and National Primary Investigator.

Gore obtained breakthrough device designation from the FDA for the Fortegra stent, which helped expedite development and FDA review of medical devices that provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.

The international clinical trial was the first prospective trial of its kind to include IVC, iliac, and iliofemoral veins. The device was shown to be safe and effective for its indicated use in 89 patients treated with deep venous disease. The study included a patient population with extensive disease burden: all were treated for thrombotic disease (acute, subacute and post-thrombotic syndrome), 94.3% of patients had lesions that span three vessel regions (IVC + bilateral iliofemoral veins) and 68.5% required stents that extended below the inguinal ligament into the common femoral vein.

Despite the study consisting of patients with extensive disease burden, 12-month primary patency was achieved in 83.4% of patients. Further, results demonstrated 96.5%, 88.9% and 89.8% primary patency in the IVC, left iliofemoral and right iliofemoral vessel regions, respectively. There were no stent embolizations/migrations, fractures, vascular injuries or clinically significant pulmonary embolisms through 12 months. There were also no device-related deaths or major bleeding through 30 days. Overall, the study met its 12-month composite efficacy and safety primary endpoint.

Yesterday, the company revealed it began a deal to acquire Conformal Medical, a company developing the investigational CLAAS AcuFORM system, a next-gen left atrial appendage occlusion (LAAO) technology.