Medtronic Gains FDA Approval for Expanded Redo-TAVR Use

Medtronic has received U.S. Food and Drug Administration (FDA) approval for the expanded Redo-TAVR indication of its Evolut transcatheter aortic valve replacement systems. The new approval permits physicians to implant an Evolut valve inside a previously failed transcatheter aortic valve, regardless of brand, providing a treatment option for patients at high surgical risk. This follows earlier CE Mark approval for Evolut PRO+, FX, and FX+ systems in Europe.

The Redo-TAVR procedure is intended for patients whose earlier valve replacement has failed, including those with severe aortic stenosis who cannot undergo repeat open-heart surgery. Severe aortic stenosis is a life-threatening condition in which the valve leaflets stiffen and obstruct blood flow, often reducing quality of life and potentially leading to death within two years if untreated.

Alongside FDA approval, Medtronic has launched the RESTORE study, which will enroll 225 patients to assess outcomes of redo procedures over a five-year period. The trial will evaluate procedural success at 30 days, as well as longer-term outcomes such as survival, stroke rates, and quality of life.

Evolut TAVR systems are already widely available for the treatment of severe aortic stenosis in native valves across all risk categories in more than 120 countries, including the United States and members of the European Union. The expanded indication broadens treatment options for patients with failing transcatheter valves and reinforces Medtronic’s role in advancing minimally invasive cardiovascular care.