Medtronic’s Evolut FX TAVR System Receives FDA Approval for Treatment of Symptomatic Severe Aortic Stenosis

August 24, 2021—Medtronic announced FDA approval of Evolut FX, the company’s newest-generation self-expanding transcatheter aortic valve replacement (TAVR) system.

A limited commercial release is planned for the fall, with a full launch anticipated in early 2022. In the United States, the Evolut TAVR platform (including Evolut R, Evolut Pro, Evolut Pro+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low), advised Medtronic.

According to the company, the Evolut FX system is designed to enhance ease of use and provide greater precision and control throughout the procedure. The device provides the hemodynamic and durability benefits of Medtronic’s Evolut platform, including a supra-annular valve design that has shown hemodynamic performance superior to surgical aortic valve replacement in large-scale randomized clinical trials. Additionally, Evolut FX incorporates product and procedure innovation for patients with symptomatic severe aortic stenosis.

Evolut FX, Medtronic’s fourth-generation Evolut technology, is equipped with gold markers built into the frame to allow direct visualization of depth and valve leaflet location during implant. In addition, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile and a more flexible delivery system that allows for 360º freedom of motion, with a stable, predictable deployment. Like its predecessor, Evolut Pro+, the new system includes four valve sizes and a low delivery profile, stated the company.