GORE® VIABAHN® FORTEGRA Venous Stent Earns FDA Approval for Venous Disease Treatment

An Innovative Breakthrough in Venous Treatment

W. L. Gore & Associates' medical division has made headlines recently with the FDA's approval of the GORE® VIABAHN® FORTEGRA Venous Stent. This significant medical device is a pioneering solution designed specifically for treating deep venous disease affecting the inferior vena cava (IVC), iliac veins, and iliofemoral veins.

Features of the FORTEGRA Stent

The FORTEGRA Stent is part of the esteemed VIABAHN® device lineup and boasts a unique design. It features an open-structure, self-expanding wire-wound nitinol frame combined with an expanded polytetrafluoroethylene (ePTFE) polymer lattice. This sophisticated engineering ensures optimal conformability while also offering impressive compression resistance, catering to a variety of patient anatomies.

Dr. Kush Desai, who serves as the National Primary Investigator, emphasizes the advancement this stent represents in addressing complex venous obstructive issues. The FORTEGRA provides both anatomical adaptability and physiologic support, enhancing blood flow dynamics in critical regions, such as the iliocaval confluence.

Clinical Insights and Study Outcomes

Gore secured Breakthrough Device designation from the FDA for the FORTEGRA stent, aiming to accelerate the development and review process for devices that present substantial improvements for severe conditions. The international clinical trial was notably the inaugural prospective study assessing the stent's application in IVC, iliac, and iliofemoral veins, demonstrating positive results across 89 patients suffering from deep venous disease.

Data from the study indicated profound efficacy, achieving a 12-month primary patency rate of 83.4%, even among patients afflicted by extensive disease burdens, such as acute, subacute, and post-thrombotic syndrome. Remarkably, follow-ups revealed no stent embolizations, migrations, fractures, vascular injuries, or major complications like clinically significant pulmonary embolisms, further strengthening the FORTEGRA's credentials as a safe option.

A Legacy of Innovation

The FORTEGRA Venous Stent is the latest testament to Gore's longstanding commitment to advancing medical technology, having successfully implanted over 55 million devices over the past five decades. This recent achievement underlines the company’s dedication to innovation fueled by rigorous research, education, and high-quality healthcare solutions.

In summary, with the approval of the GORE® VIABAHN® FORTEGRA Venous Stent, patients facing severe venous conditions now have access to a specially designed device that offers not only enhanced safety and effectiveness but also a brighter outlook for their medical treatment journey. The unique properties of this stent pave the way for improved patient care, promoting better health outcomes in an often-overlooked area of vascular health.