Medtronic Reports FDA Approval Of Evolut FX TAVR System - Quick Facts

(RTTNews) - Medtronic plc (MDT) announced FDA approval of Evolut FX TAVR system, the company's self-expanding transcatheter aortic valve replacement system, for Treatment of Symptomatic Severe Aortic Stenosis. The company said its Evolut FX system maintains the hemodynamic and durability benefits of the Evolut platform.

The Evolut FX system comes with a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment.

The Evolut TAVR platform in the U.S. Limited commercial release is planned for the fall with a full launch expected in early 2022.