Medtronic has received CE mark for the Evolut FX+ transcatheter aortic valve implantation (TAVI) system for the treatment of symptomatic severe aortic stenosis. This follows the recent US Food and Drug Administration (FDA) approval of the system in March 2024.
The latest Evolut FX+ TAVI system offers three larger coronary access windows through a modified diamond-shaped frame design, which are four times larger than regular cells of the Evolut TAVI system.
Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. The design builds on the leading valve performance, excellent durability, and excellent outcomes that clinicians expect from the Evolut platform.
“We are excited to complete this momentous milestone and expand our solutions for severe aortic stenosis across Europe,” said Jorie Soskin, vice president and general manager, Structural Heart within the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio 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.”
“The Medtronic Evolut FX+ system represents a significant step forward in the evolution of heart valve disease care,” said Didier Tchetche, interventional cardiologist and director of the Structural Heart Disease Department at Clinique Pasteur in Toulouse, France. “This advanced technology enables coronary access across multiple patient anatomies and offers clinicians a contemporary tool to improve outcomes without compromising an established valve performance. We are excited to see this innovative solution approved in European regions and look forward to using it for the benefit of patients.”
The Evolut FX+ TAVI system is indicated for symptomatic severe aortic stenosis adult patients across all risk categories (extreme, high, intermediate, and low) in the European Union and is also indicated for symptomatic severe aortic stenosis patients across all risk categories in the USA. The Evolut FX+ system is expected to be commercially available across Europe in the coming weeks as teams and physicians are trained on this new technology.
