Medtronic’s Evolut FX+ TAVR System Gains FDA Approval

March 27, 2024—Medtronic announced that the FDA has approved the company’s Evolut FX+ transcatheter aortic valve replacement (TAVR) system, which is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the United States.

Early commercial experience is planned for spring 2024 with full product launch anticipated in summer 2024, advised Medtronic.

According to the company, the Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform. It is designed to facilitate coronary access with larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system.

Additionally, Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies.

Finally, the new design does not compromise the valve performance, hemodynamics, and radial strength that of the Evolut platform, stated Medtronic.