Medtronic gains a key approval for Evolut TAVR valves

Michael Walter | May 21, 2025 | Cardiovascular Business | TAVR

Medtronic Evolut FX TAVR valve. Medtronic has received an additional CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves; they can now be used for redo TAVR in addition to traditional TAVR procedures.

Medtronic has received an additional European CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves. They can now be used for redo TAVR in addition to traditional TAVR procedures.

This expanded indication significantly increases patient access to redo TAVR in patients with a failed heart valve from any manufacturer.

“The CE mark approval for the Evolut TAVR system's redo TAVI 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,” Dan Blackman, MD, MBChB, BRCP, a consultant interventional cardiologist with Leeds Teaching Hospitals NHS Trust, said in a prepared statement. “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.”

“Redo TAVR indication builds upon the Evolut platform’s proven valve performance and durability to offer safe and reliable lifetime management options, providing physicians exceptional patient outcomes today, while maintaining important options for the future,” added Jorie Soskin, vice president and general manager of Medtronic’s structural heart business. “This approval is a testament to Medtronic’s ongoing commitment to advance patient care and expand treatment options and access around the globe.”

Medtronic’s Evolut TAVR platform is currently approved for TAVR in patients with symptomatic severe aortic stenosis across all risk categories—extreme, high, intermediate and low—in both the European Union and the United States.

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Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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