Medtronic’s Evolut Systems Receive Expanded Redo TAVR Indication in Europe

May 21, 2025—Medtronic announced it received European CE Mark approval for the expanded redo transcatheter aortic valve replacement (TAVR) indication of the Evolut Pro+ and FX TAVR systems.

According to Medtronic, the approval allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed previously implanted TAV. The redo TAVR procedure is indicated for patients with severe aortic stenosis with the failure of any TAV, regardless of the manufacturer, and for those patients at high risk for open heart surgery. In native (ie, nonprosthetic) aortic valves, Evolut TAVR systems are currently indicated for implantation in symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the European Union and the United States, advised Medtronic.

“The CE Mark approval for the Evolut TAVR system’s redo TAVR procedure is great news for physicians working in this field, but most importantly for patients with failing transcatheter heart valves, who now have a crucial new treatment option,” commented Professor Dan Blackman, MD, in Medtronic’s press release. “This minimally invasive procedure not only offers an alternative for patients at high risk for surgery but also underscores the commitment to improving outcomes and extending the benefits of TAVR therapy.”

Professor Blackman is a consultant interventional cardiologist at Leeds Teaching Hospitals NHS Trust in Leeds, United Kingdom.