Medtronic’s Evolut FX+ TAVR System Approved in Europe

October 24, 2024—Medtronic announced it has received CE Mark approval for the Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The device is the company’s latest Evolut TAVR system.

According to Medtronic, the Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis adult patients across all risk categories (extreme, high, intermediate, and low) in the European Union.

The company advised that the Evolut FX+ system is expected to be commercially available across Europe in the coming weeks as teams and physicians are trained on this new technology.

Medtronic stated that the Evolut FX+ TAVR system provides three larger coronary access windows through a modified diamond-shaped frame design, which are four times larger than regular cells of the Evolut TAVR system. Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. The new design builds on the performance, durability, and outcomes of the Evolut platform, noted the company.

In the United States, the Evolut FX+ is indicated for symptomatic severe aortic stenosis patients across all risk categories in the United States. In March 2024, the company announced FDA approval of the Evolut FX+ system

“The Medtronic Evolut FX+ system represents a significant step forward in the evolution of heart valve disease care,” commented Didier Tchetche, MD, in the press release.

Dr. Tchetche, who is an interventional cardiologist and the director of the Structural Heart Disease Department at Clinique Pasteur in Toulouse, France, continued, “This advanced technology enables coronary access across multiple patient anatomies and offers clinicians a contemporary tool to improve outcomes without compromising an established valve performance. We are excited to see this innovative solution approved in European regions and look forward to using it for the benefit of patients.”