W. L. Gore & Associates has received CE Mark approval under the Medical Device Regulation (MDR) for its GORE VIABAHN FORTEGRA Venous Stent. The device is intended for the treatment of symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction. The approval follows the product’s recent clearance by the U.S. Food and Drug Administration (FDA) and supports the company’s efforts to expand access to specialised venous treatment options.

The FORTEGRA Venous Stent is the latest addition to the VIABAHN device portfolio and has been developed specifically for patients with deep venous disease. The device features a self-expanding wire-wound nitinol frame with a polymer lattice designed to provide flexibility, strength and resistance to fracture.

According to Gore, the stent is designed to adapt to the body’s natural anatomy while maintaining resistance to compression throughout the device. It is available in a wide range of sizes to accommodate different patient anatomies.

The device was assessed in a prospective clinical study, which was the first trial to include the IVC, iliac and iliofemoral veins. Study findings showed that the stent was both safe and effective for its intended use in patients with deep venous disease.

Among patients who reported pain at the start of the study, 81% experienced pain improvement after 12 months, with a median pain score reduction of 2 points. The study also reported notable improvements in quality-of-life measures, as well as reductions in clinical severity indicators such as oedema and ulcer-related complications.

Primary patency remained high at 83.4% after 12 months, and no device-related safety concerns were identified during the study. Researchers noted that the trial covered a broad range of thrombotic conditions, including acute, subacute and post-thrombotic syndrome cases, providing evidence across the spectrum of patients commonly treated in clinical practice.

The results also highlighted meaningful clinical benefits for patients with complex venous conditions involving the inferior vena cava, iliac veins and inflow veins, alongside improvements in quality of life and disease severity outcomes.

 

Source: goremedical.com

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