Medtronic's Evolut FX TAVR System Receives Approval for Severe Aortic Stenosis

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With approval of the Evolut FX TAVR System announced on August 24, the Evolut TAVR Platform is now indicated for symptomatic severe aortic stenosis across all patient risk categories.

FDA written in bold, white lettering on a blue backdrop

The Evolut FX system has received approval from the US Food and Drug Administration (FDA) for use in the treatment of symptomatic severe aortic stenosis, according to a release from Medtronic.

Medtronic’s newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, approval of the Evolut FX TAVR system means the Evolut TAVR Platform, which also includes Evolut R, Evolut PRO, and Evolut PRO+, is indicated for symptomatic severe aortic stenosis patients across all risk categories in the US.

"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," said Jeffrey Popma, MD, vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, in the aforementioned release.

Few therapeutic advances have received the same attention as TAVR in recent years. An evolution that has allowed for shorter hospitalizations and less adverse event risk than the previous standard of care, developments in TAVR have the potential to significantly alter the disease management and outcomes among patients with aortic stenosis.

Designed to improve ease-of-use and enhance precision throughout the procedure, the Evolut FX system uses the same design supra-annular valve design that has shown hemodynamic performance superior to SAVR as other Evolut systems. The fourth-generation technology also sports a redesigned catheter tip for a smoother insertion profile and a more flexible delivery system allowing for 360-degree freedom of motion.

In their release, Medtronic noted plans for a limited commercial release in fall of 2021 with a full launch of the Evolut FX system planned for early 2022.

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