Medtronic has announced that the US Food and Drug Administration (FDA) has approved the Evolut FX+ transcatheter aortic valve implantation (TAVI) system for the treatment of symptomatic severe aortic stenosis.
The latest Evolut FX+ TAVI system maintains the valve performance of the legacy Evolut TAVI platform and is designed to facilitate coronary access.
The Evolut FX+ TAVI system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of Evolut. Evolut FX+ provides increased space for catheter manoeuvrability to facilitate access to coronary arteries of varying patient anatomies.
“We are committed to consistently developing and advancing minimally invasive solutions for physicians to treat their patients with aortic stenosis. This is reinforced by our continued innovation of the Evolut TAVI platform, which has delivered proven valve performance and durability to physicians and patients for years. The Evolut FX+ TAVI system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance,” said Jeffrey Popma, 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.
The Evolut FX+ TAVI system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the USA. Early commercial experience is planned for spring 2024 with full product launch anticipated in summer 2024.
