Medtronic announces US FDA approval of Evolut TAVR system for symptomatic SAS treatment

27th March, 2024

To leverage market-leading valve performance with the addition of larger windows to facilitate coronary access

Medtronic has announced the United States Food and Drug Administration (FDA) approval of its Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis (SAS).

The Evolut FX+ TAVR system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system. Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. Additionally, the new design does not compromise valve performance and specializes in providing optimum hemodynamics, and radial strength.

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the US Early Commercial Experience is planned for spring 2024 with a full product launch anticipated in summer 2024.