GORE® VIABAHN® FORTEGRA Venous Stent Achieves CE Mark Approval

GORE® VIABAHN® FORTEGRA Receives CE Mark Approval

W. L. Gore & Associates, a leader in medical products, revealed on June 9, 2026, that its GORE® VIABAHN® FORTEGRA venous stent has obtained CE mark approval. This significant milestone allows for its use in treating symptomatic obstructions in the inferior vena cava (IVC) and ilio-femoral venous flow issues. This approval follows the recent authorization from the U.S. FDA, marking a crucial step in expanding treatment options for patients worldwide.

Innovative Design for Unique Needs

The FORTEGRA stent is the latest addition to the VIABAHN® family, tailored specifically for patients experiencing deep vein disease. It features a self-expanding nitinol framework combined with a polymer mesh, striking a balance between conformity and durability while resisting compression. Its versatile design caters to a diverse range of patient anatomies, enhancing its applicability in various clinical scenarios.

Professor Stephen Black, a leading vascular surgeon at Guy's and St Thomas' Hospital in London, touted the FORTEGRA stent as a major breakthrough for treating complex venous obstructions, particularly those related to the inferior vena cava and ilio-femoral veins. "The stent is particularly crafted for these unique anatomical challenges, ensuring optimal blood flow dynamics obstructed by the anatomy of the vessels," he explained.

Clinical Validation and Outcomes

The FORTEGRA venous stent was put through a prospective trial – a first of its kind focusing on the IVC and ilio-femoral veins. The results showed that the stent is both safe and effective, with a remarkable 81% of patients who reported pain at baseline indicating significant pain alleviation after 12 months. The median pain score reduction stood at -2.0 (p<0.001), showcasing impressive improvement in validated quality of life measurements and clinical severity metrics such as edema and ulcer outcomes.

Professor Gerry O'Sullivan, an interventional radiologist in Galway, Ireland, expressed his enthusiasm about the study findings, declaring they conclusively demonstrated the clinical significance of the stent for patients with complex cases involving vital venous structures.

A Legacy of Transformation in Medical Technology

The FORTEGRA stent builds on Gore’s legacy, with over 55 million medical devices successfully implanted in the past 50 years. Known for revolutionizing medical technology through rigorous research, educational initiatives, and quality standards, Gore emphasizes both product performance and service quality. The combination of these factors equates to long-term value for healthcare providers and patients alike.

For additional information on the FORTEGRA venous stent, interested parties can explore Gore’s official website at goremedical.com.

Gore continues to design medical devices that address various cardiovascular issues and improve overall patient outcomes with over 55 million devices implanted across more than 45 years. By focusing on innovation, effectiveness, and reliability, Gore collaborates with clinicians to enhance people's quality of life around the world.

About Gore

Founded in 1958, W. L. Gore & Associates is a global leader in material science, aiming to innovate industries and improve lives. The company addresses complex technical challenges in demanding environments, ranging from outer space to the human body. With approximately 13,000 associates generating an annual revenue of $5.3 billion, Gore is dedicated to quality assurance, user-friendliness in products, and fostering meaningful partnerships.