GORE® Announces Expanded Indication for VIABAHN® VBX Endoprosthesis as a Bridging Stent Under MDR Approval
Flagstaff, Arizona – July 9, 2025 – W. L. Gore & Associates, Inc. (Gore) is pleased to announce a significant advancement in the treatment of peripheral arterial disease (PAD). The company has received expanded indication approval under the Medical Device Regulation (MDR) for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, authorizing its use as a bridging stent. This development promises to enhance treatment options and improve outcomes for patients requiring intervention in challenging lower limb arterial lesions.
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis has been a trusted device in the interventional cardiology and vascular surgery fields, known for its robust design and reliable performance. The new MDR-approved indication as a bridging stent offers physicians greater flexibility and confidence when treating complex arterial anatomies, particularly in cases where initial stenting may require subsequent or complementary treatment.
This expanded indication signifies Gore’s continued commitment to innovation and patient-centric solutions in vascular therapy. By enabling the VIABAHN® VBX Endoprosthesis to be utilized as a bridging stent, healthcare professionals can now leverage its proven track record and advanced technology to facilitate more comprehensive and potentially less invasive treatment strategies for patients suffering from the debilitating effects of PAD.
The ability to use the VIABAHN® VBX Endoprosthesis as a bridging stent is expected to be particularly beneficial in situations involving long-segment occlusions, heavily calcified lesions, or tortuous anatomy. This allows for a more controlled and precise approach to revascularization, potentially reducing the need for more complex or aggressive interventions.
Gore’s dedication to advancing medical device regulations and ensuring the highest standards of safety and efficacy is reflected in this achievement. The MDR approval process rigorously evaluates medical devices to ensure they meet the latest EU safety and performance requirements. This expanded indication underscores the continued clinical value and safety profile of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Further details regarding the expanded indication and its clinical applications are expected to be shared with the medical community through scientific publications and presentations. Gore remains dedicated to collaborating with healthcare professionals to improve the lives of patients affected by vascular disease.
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