The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access.
Evolut FX+ TAVR offers larger coronary access windows through a modified diamond-shaped frame design. It comes in four times larger than previous iterations of the Evolut system. With this design, the system provides increased space for catheter maneuverability, facilitating access to coronary arteries in varying anatomies.
Additionally, Medtronic said its new design doesn’t compromise the valve’s performance, hemodynamics or radial strength. Evolut FX+’s indication extends to all risk categories (extreme, high, intermediate and low) as well.
The medtech giant plans to begin an early commercial rollout in the U.S. this spring. It expects a full launch in summer 2024.
Dr. Jeffrey Popma, VP and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business — part of the Cardiovascular Portfolio at Medtronic — said Evolut FX+ reflects the company’s commitment to developing and advancing minimally invasive solutions for treating patients with aortic stenosis.
He said the company designed it to facilitate coronary access across a range of patients with no compromise to performance.
“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,” Popma said in a news release.
