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# Medtronic Wins Expanded Use for Evolut Aortic Valve
- URL: https://www.fdaweb.com/medtronic-wins-expanded-use-for-evolut-aortic-valve/
- Published: 2025-08-29T12:00:00.000Z
- Updated: 2026-09-14T15:20:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159786

FDA has approved an expanded use for Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) system, allowing implantation of a new Evolut valve inside any previously implanted transcatheter aortic valve that has failed. The action broadens treatment options for patients with severe aortic stenosis or other valve failure who are considered high risk for open-heart surgery, according to the company.

Medtronic says the expanded indication also supports patients undergoing TAVR for the first time, providing more options for potential future interventions. Severe aortic stenosis, in which valve leaflets thicken and restrict blood flow, can be fatal within two years if left untreated, it says.

Together with the approval, Medtronic launched the RESTORE study, a pivotal trial that will track 225 patients over five years to evaluate safety, procedural success, and long-term outcomes of redo-TAVR procedures. The trial will measure 30-day success rates, one-year freedom from death and stroke, and impacts on quality of life.

Evolut was previously approved for use in native aortic valves with symptomatic severe aortic stenosis across all surgical risk categories.