Next-generation self-expanding TAVR system garners FDA approval
Medtronic announced the FDA has approved its next-generation self-expanding transcatheter aortic valve replacement system for patients with severe symptomatic aortic stenosis.
According to a press release from the company, the fourth-generation system (Evolut FX) has gold markers on the frame to help operators better visualize depth and valve leaflet location during implantation.
The new system also has a redesigned catheter tip to improve insertion and an improved delivery system offering a more flexible range of motion, according to the release.
"The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimize paravalvular leak. Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," Jeffrey Popma, MD, vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business in Medtronic’s cardiovascular portfolio, said in the release.
The device will have a limited rollout in the fall and a full launch in 2022, according to the release.