Medtronic’s Evolut FX TAVI System Receives CE Mark Approval

October 13, 2023—Medtronic announced it has received European CE Mark approval for the Evolut FX transcatheter aortic valve replacement/implantation (TAVR/TAVI) system, the newest-generation system of the company’s CoreValve/Evolut TAVI platform.

According to Medtronic, the Evolut FX system is indicated for severe aortic stenosis (AS) in adult patients across all risk categories (extreme, high, intermediate, and low) in the European Union and is indicated for symptomatic severe AS patients across all risk categories in the United States. The company advised that 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.

Medtronic noted that the Evolut FX TAVI platform is designed to enhance ease of use and provide greater precision and control throughout the procedure for clinicians treating patients with severe AS. The Evolut FX system incorporates the same supra-annular, self-expanding valve design as the CoreValve/Evolut platform, which has been shown to have superior hemodynamic performance compared to surgical aortic valve replacement (SAVR) at 1 year across three separate large-scale, randomized controlled trials.

Additionally, the fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet orientation during implantation. Furthermore, the Evolut FX system incorporates a redesigned catheter for a smoother insertion profile and a more flexible delivery system for a stable, predictable deployment, noted the press release.

The CoreValve/Evolut platform has demonstrated a durability advantage over SAVR at 5 and 10 years in a randomized trial, noted the company.

“With the latest Evolut FX system, we are elevating the precision, control, and predictability of TAVR procedures for patients with severe AS,” commented Danny Dvir, MD, in Medtronic’s press release. “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.” Dr. Dvir is an interventional cardiologist and Director of Interventional Cardiology and Cath Labs at Shaare Zedek Hospital Canter in Jerusalem, Israel.