US EditionAbbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery
- Abbott received FDA approval on May 27, 2025, for its Tendyne TMVR system to treat severe mitral annular calcification in the United States.
- This approval follows nearly a decade of development to address patients with high surgical risk whose valves cannot be repaired by existing devices like MitraClip.
- The Tendyne valve is a self-expanding, repositionable device delivered via a small chest incision, available in multiple sizes to fit various anatomies and replace valves impaired by mitral regurgitation or stenosis.
- Dr. Paul Sorajja emphasized that Tendyne offers an important therapeutic option for patients with MAC who are often unsuitable for conventional surgery, improving their symptoms and overall daily functioning.
- The approval expands Abbott's structural heart portfolio with a minimally invasive option for patients who are poor candidates for open-heart surgery, potentially improving treatment outcomes in mitral valve disease.
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Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition
Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.
Farm Talk Newspaper
Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery
The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC)Tendyne offers a new treatment option for patients who are not…
FDA approves Abbott's Tendyne system for non-surgical mitral valve replacement
Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved its Tendyne transcatheter mitral valve replacement (TMVR) system. This device is designed to treat individuals with mitral valve disease, specifically those whose valves are compromised due to severe mitral annular calcification (MAC). MAC involves a buildup of calcium in the annulus, the structure supporting the mitral valve.The approval introduces a new treatmen…
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