FDA Approves Redo TAVR Indication for Medtronic’s Evolut Systems

August 28, 2025—Medtronic announced it received FDA approval for an expanded indication of the Evolut transcatheter aortic valve replacement (TAVR) systems. The approval for a redo TAVR indication allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed, previously implanted TAV.

According to Medtronic, the redo TAVR procedure is indicated for patients experiencing failure of any TAV, including but not limited to severe aortic stenosis, who are at high-risk for open heart surgery.

In May 2025, the company announced CE Mark approval for the expanded indication of redo TAVR for the Evolut Pro+, FX, and FX+ systems.

Michael Caskey, MD, attending cardiothoracic surgeon at Abrazo Arizona Heart Hospital in Phoenix, Arizona, commented on the approval in the company’s press release.

“FDA approval for redo TAVR with the Evolut system marks a significant milestone in patient care, empowering physicians across the United States to offer a critical treatment option for patients with failing TAVs who are at high surgical risk,” stated Dr. Caskey. “This advancement also benefits patients considering a new TAVR procedure today, giving patients options for future intervention, and has the potential to profoundly improve their long-term outcomes and quality of life.”

In addition to the FDA approval of the expanded indication, Medtronic advised it has launched the RESTORE study to evaluate the outcomes of redo TAVR in patients experiencing symptomatic bioprosthetic valve failure.

The pivotal study will enroll 225 patients with 5-year follow-up, focusing on both immediate and long-term clinical outcomes. It will assess 30-day procedural success rates; 1-year freedom from mortality and stroke; and additional measures of safety, technical success, and quality of life, advised Medtronic.