Medtronic receives CE mark for Evolut FX TAVI system to treat severe aortic stenosis


Medtronic has received CE mark for the Evolut FX transcatheter aortic valve implantation (TAVI) system, the newest generation of its CoreValve/Evolut TAVI platform.

In a press release, Medtronic states that the Evolut FX system is designed to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis. The CoreValve/Evolut platform is the only TAVI platform to demonstrate a durability advantage over SAVR at five and 10 years in a randomized trial.

The Evolut FX system incorporates the same supra-annular, self-expanding valve design as the CoreValve/Evolut platform which has shown to have a superior hemodynamic performance compared to surgical aortic valve replacement (SAVR) at one-year across three separate, large-scale, randomised controlled trials.

The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualisation of depth and valve leaflet orientation during implant. In addition, the Evolut FX system incorporates a redesigned catheter for a smoother insertion profile and a more flexible delivery system for a stable, predictable deployment.

“With the latest Evolut FX system, we are elevating the precision, control and predictability of transcatheter aortic valve replacement procedures for patients with severe aortic stenosis,” said Danny Dvir (Shaare Zedek Hospital Canter, Jerusalem, Israel). “The system provides physicians with an innovative solution to meet the needs of a patient population desiring to get back to their active lifestyles sooner.”

“This exciting milestone helps us continually enhance a trusted platform to better respond to clinicians’ needs making TAVI procedures easier to visualise and more predictable for heart teams,” 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. “Receiving CE mark for the Evolut FX system highlights our commitment to providing minimally invasive treatment options globally for patients experiencing severe aortic stenosis.”

The Evolut FX system is indicated for severe aortic stenosis in adult patients across all risk categories (extreme, high, intermediate, and low) in the European Union (EU) and is 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.


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