Medtronic's Evolut Pro+ and FX Transcatheter Aortic Valve Replacement (TAVR) valves have received additional European CE mark approval. In addition to traditional TAVR procedures, they can now also be used for Redo-TAVR.

This expanded indication significantly increases the opportunity for redo TAVR in patients with failed heart valves.

"The CE Mark Approval for Redo-TAVI with the Evolut TAVR System is great news for physicians working in this field, but most importantly for patients with failed transcatheter heart valves, who now have a significant new treatment option. This minimally invasive procedure not only offers an alternative for patients at high surgical risk but also underscores the commitment to improving outcomes and expanding the benefits of TAVR therapy.""Dan Blackman, MD, Consultant Interventional Cardiologist at Leeds Teaching Hospitals NHS, stated."

Jorie Soskin, Vice President and General Manager of Medtronic's Structural Heart business, said: "The Redo TAVR indication builds on the proven valve performance and durability of the Evolut platform, offering a safe and reliable lifetime management option that provides physicians with today’s superior patient outcomes while preserving important options for the future. This approval demonstrates Medtronic's ongoing commitment to advancing patient care, expanding global treatment options, and increasing accessibility."

Medtronic's Evolut TAVR platform is currently approved in the EU and the U.S. for TAVR in symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low).