
6. Medtronic: Evolut FX TAVR system
Medtronic won FDA approval for its Evolut FX TAVR system in August 2021.
The company designed the self-expanding transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis.
The TAVR system uses a supra-annular valve design that has demonstrated hemodynamic performance that is superior to surgical aortic valve replacement in large-scale, randomized clinical trials, according to the company. In addition, it has gold markers built into the frame to provide direct visualization of depth and valve leaflet location during an implant.
Evolut FX has a redesigned catheter tip for a smoother insertion profile and a more flexible delivery system that has 360º freedom of motion with stable and predictable deployment. Like Medtronic’s Evolut Pro+, the Evolut FX has four valve sizes for a large indicated patient treatment range and a low delivery profile.
Read more about Evolut FX TAVR’s approval here.