Gore Announces Expanded MDR Indication for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Enhancing Treatment Options for Complex Peripheral Artery Disease
Flagstaff, Arizona – July 9, 2025 – W. L. Gore & Associates, Inc. (Gore) today announced a significant milestone with the expansion of the Medical Device Regulation (MDR) indication for its GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. This enhancement allows for a broader application of this innovative device in treating patients suffering from complex femoropopliteal arterial disease, marking a positive development for both clinicians and patients.
The GORE® VIABAHN® VBX Endoprosthesis is a testament to Gore’s unwavering commitment to advancing vascular care through cutting-edge medical technology. Designed for challenging peripheral anatomies, the VBX Endoprosthesis offers a unique combination of flexibility, radial strength, and durability. The expansion of its MDR indication signifies rigorous clinical evaluation and validation, confirming its safety and efficacy in a wider range of patient cases.
This updated indication will empower interventionalists with greater confidence and expanded treatment possibilities when addressing complex lesions in the femoropopliteal arteries. These arteries, located in the thigh and the back of the knee, are frequently affected by peripheral artery disease (PAD), often leading to pain, reduced mobility, and in severe cases, limb-threatening conditions. Complex PAD can involve long occlusions, calcified lesions, and challenging anatomical configurations, making treatment more intricate.
“We are delighted to announce this expanded MDR indication for the GORE® VIABAHN® VBX Endoprosthesis,” stated [Insert Name and Title of a Gore Representative, e.g., Sarah Chen, Vice President of Vascular Business at Gore]. “This is a significant step forward in our mission to provide physicians with advanced solutions that improve patient outcomes. The VBX Endoprosthesis has already demonstrated its effectiveness in treating challenging PAD cases, and this expanded indication will enable us to reach more patients who can benefit from its unique design and performance characteristics.”
The GORE® VIABAHN® VBX Endoprosthesis is distinguished by its supra-annular design, which allows for precise placement and excellent apposition to the vessel wall, even in tortuous anatomies. Its proprietary ePTFE-free nitinol stent-graft technology offers enhanced conformability and kink resistance, crucial attributes for successful treatment in the dynamic femoropopliteal segment. The balloon-expandable nature of the device facilitates precise deployment and optimal lumen gain.
With this expanded indication, healthcare providers can now consider the GORE® VIABAHN® VBX Endoprosthesis for a broader spectrum of complex femoropopliteal interventions. This advancement is expected to contribute to improved procedural success rates, enhanced long-term patency, and ultimately, a better quality of life for patients struggling with the debilitating effects of PAD.
Gore continues to invest heavily in clinical research and development to ensure its products meet the evolving needs of the medical community and the patients they serve. This latest regulatory achievement underscores the company’s dedication to innovation and its role as a leader in vascular therapies.
About W. L. Gore & Associates, Inc. W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for innovation, quality, and collaborative culture. Gore’s diverse portfolio includes advanced materials, medical devices, aerospace technologies, and industrial solutions. In the healthcare sector, Gore is renowned for its vascular grafts, endovascular grafts, and surgical meshes, which are used in a wide range of complex medical procedures. Gore is committed to developing life-changing medical technologies that enhance patient outcomes and advance the field of medicine.
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PR Newswire Healthring published ‘Gore anuncia la ampliación de la indicación MDR para la endoprótesis expandible con balón GORE® VIABAHN® VBX’ at 2025-07-09 05:07. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.