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BioWorld - Monday, May 18, 2026
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Home » FDA approves Medtronic Evolut for expanded redo TAVR indication
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FDA approves Medtronic Evolut for expanded redo TAVR indication

Aug. 28, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.
Medical technology Regulatory TAVR Cardiovascular U.S. 510(k) FDA

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