Medtronic Evolut TAVI Systems Receive CE Mark for Expanded Redo TAVI Indication in Europe

Reuters
21 May
Medtronic Evolut TAVI Systems Receive CE Mark for Expanded Redo TAVI Indication in Europe

Medtronic plc, a global leader in healthcare technology, has received the CE (Conformité Européenne) Mark for the expanded redo TAVI indication of its Evolut™ PRO+ and FX transcatheter aortic valve implantation $(TAVI)$ systems. This regulatory approval allows the implantation of a new Evolut transcatheter aortic valve inside any failed previously implanted TAV, regardless of the manufacturer. The redo TAVI procedure is specifically indicated for patients with severe aortic stenosis who are at high risk for open-heart surgery. This development provides a crucial new treatment option for patients with failing transcatheter heart valves, offering a minimally invasive alternative that underscores Medtronic's commitment to advancing patient care and expanding global treatment options.

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