The medtech giant received FDA approval for the same system in March of this year. Both FDA and CE mark approval cover the treatment of symptomatic severe aortic stenosis. It 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 three larger coronary access windows through a modified diamond-shaped frame design. The access windows are four times larger than previous iterations of the Evolut system. This design 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.
Medtronic plans to make the Evolut FX+ system available across Europe in the coming weeks.
“We are excited to complete this momentous milestone and expand our solutions for severe aortic stenosis across Europe,” said Jorie Soskin, VP and GM for Structural Heart at Medtronic. “Through our promise of continued innovation for the Evolut TAVI platform, we have delivered a more advanced and minimally invasive treatment option with proven valve performance and durability to physicians and patients across the globe.”
