The US Food and Drug Administration has approved Medtronic's Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all risk levels.
The Evolut FX system features a self-expanding, supra-annular valve and is designed to "enhance ease-of-use and provide greater precision and control throughout the procedure," the company said in a news release.
The fourth-generation device is equipped with gold markers built into the frame to provide direct visualization of depth and valve leaflet location during implant.
Additionally, it has a redesigned catheter tip for a smoother insertion profile and a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment, Medtronic noted.
Similar to its predecessor, the Evolut PRO+, the new system will be available in 23, 26, 29, and 34 mm sizes and has the lowest delivery profile currently on the market, according to the company.
Limited commercial release is planned for the fall, with a full launch set for early 2022.
Cite this: FDA Approves Medtronic's Next-Gen Evolut FX TAVR System - Medscape - Aug 24, 2021.