FDA Expands Evolut Indications to Include Redo TAVI

The US Food and Drug Administration has expanded its indications for the Evolut family of valves (Medtronic) to include redo TAVI inpatients at high risk for surgery.

The approval now includes use for patients with, but not limited to, severe aortic stenosis who have failing TAVI valves from any manufacturer and covers the Evolut PRO+, FX, and FX+ systems, Medtronic announced in a press release. The Evolut valves received a similar indication expansion of its CE Mark in Europe in May.

“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 transcatheter heart valves who are at high surgical risk,” said cardiothoracic surgeon Michael Caskey, MD (Abrazo Arizona Heart Hospital, Phoenix, AZ), in the company’s statement. “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.”

The broader indication means that physicians planning redo TAVI cases now have more choices than the Sapien valves (Edwards Lifesciences), which also are approved for valve-in-valve procedures..

Medtronic simultaneously announced its RESTORE study to look at longer-term outcomes with redo TAVI among 225 patients with symptomatic bioprosthetic valve failure.