GORE® VIABAHN® FORTEGRA Venous Stent Receives CE Mark Approval

GORE® VIABAHN® FORTEGRA Receives CE Mark for Venous Treatment

W. L. Gore & Associates, a leader in medical technologies, has recently made an impactful announcement regarding the GORE® VIABAHN® FORTEGRA venous stent. This innovative medical device has officially received CE mark approval for treating symptomatic lower vena cava (IVC) and iliofemoral venous obstructions. This significant milestone illustrates Gore's commitment to enhancing patient care by providing tailored treatment options for diverse patient anatomies.

The FORTEGRA venous stent represents the latest advancement in the VIABAHN® device family. Purposefully engineered for patients grappling with deep vein diseases, this stent is composed of a self-expanding, wire-woven nitinol framework that offers an open structure along with a polymer mesh. Its unique attributes are designed to provide an optimal balance between adaptability, strength, and resistance to breakage, ensuring a seamless fit into the natural anatomy of patients while maintaining consistent compression resistance across the device.

Prof. Stephen Black, a leading expert in venous surgery at Guy's and St Thomas' Hospital in London, emphasized the significant advancement the FORTEGRA venous stent represents. He stated that the stent is particularly beneficial for patients facing the most challenging forms of venous obstruction, specifically lower IVC and pelvic vein blockages. The stent is crafted keeping in mind the unique anatomical and physiological challenges of these conditions, effectively preserving optimal blood flow dynamics by reconstructing the ilio-caval confluence.

A prospective study, the first of its kind to include IVC, iliac, and iliofemoral veins, rigorously tested the FORTEGRA device. Results indicated that the stent is not only safe and effective for the indicated uses but also provides remarkable improvements in patient well-being. In fact, 81% of patients who experienced pain prior to treatment reported significant alleviation after 12 months, along with a median decrease in pain scores, underscoring the device's clinical efficacy (p<0.001). Additionally, various validated quality of life metrics demonstrated notable enhancements, alongside clinically significant improvements in severity assessments of conditions such as edema and ulcer-related outcomes.

The FORTEGRA venous stent showcases a primary patency rate of 83.4% after a year, with the study revealing no safety concerns associated with the device. Prof. Gerry O'Sullivan, an interventional radiologist at Galway University Hospital, Ireland, noted that these findings reflect the broad thrombotic spectrum encountered in clinical practice, including acute, subacute, and post-thrombotic syndromes.

This groundbreaking advancement in venous treatment is rooted in Gore's extensive heritage of over 55 million implanted medical devices spanning five decades. The company is driven to transform medical technologies through relentless research, education, and quality initiatives that ultimately enhance patient outcomes. A user-centric approach in product design, alongside strong service quality, provides long-term value to healthcare providers and payers alike, helping to enhance patients’ quality of life overall.

For additional information on the FORTEGRA venous stent and its implications, you can visit Gore Medical.

About W. L. Gore & Associates

Founded in 1958, W. L. Gore & Associates is a globally recognized materials science company dedicated to revolutionizing industries and improving lives through innovative solutions. Specializing in advanced technology applications, Gore has succeeded in addressing complex challenges in harsh environments—ranging from outer space to the summit of the world’s highest peaks, and even inside the human body. Boasting approximately 13,000 employees and a robust organizational culture, Gore generates annual revenues of $5.3 billion.

For comprehensive information on product indications, warnings, precautions, and contraindications in relevant markets, please refer to the device's instruction manual available at Gore's Eifu. Please be aware that product availability may differ depending on the region.