Medtronic has received US FDA approval for the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic severe aortic stenosis in all risk categories (extreme, high, intermediate and low) in the US.

The Evolut FX+ TAVR system offers larger coronary access windows through a modified diamond-shaped frame design that is four times larger than previous iterations of the Evolut TAVR system, providing increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. Early Commercial Experience is planned for spring 2024, with full product launch anticipated in summer 2024.

This is reinforced by our continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years. The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance,” said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic.

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