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Abbott Says Tendyne Transcatheter Mitral Valve Replacement System Receives FDA Approval
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Abbott Says Tendyne Transcatheter Mitral Valve Replacement System Receives FDA Approval
May 27, 2025 7:02 AM

09:37 AM EDT, 05/27/2025 (MT Newswires) -- Abbott (ABT) said Tuesday its Tendyne transcatheter mitral valve replacement system for the treatment of mitral valve disease received approval from the US Food and Drug Administration.

The company said the system provides patients who are not candidates for open-heart surgery or mitral repair with a new treatment option.

Abbott said Tendyne is an alternative minimally invasive method to replace a leaky or narrowed valve for patients with severe mitral annular calcification who are at high risk for open-heart surgery and whose mitral valve cannot be repaired with its MitraClip device.

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