Medtronic's Newest Evolut TAVR System FDA Approved for Aortic Stenosis Treatment

Thursday, March 28, 2024

Medtronic plc has announced the FDA's approval of their Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for managing symptomatic severe aortic stenosis. This latest iteration of the Evolut TAVR platform maintains the advantages of its predecessor while incorporating design enhancements to ease coronary access.

The Evolut FX+ TAVR system features a modified diamond-shaped frame design, allowing for larger coronary access windows compared to previous versions. This enhancement, which is four times larger than before, facilitates catheter maneuverability, enabling access to coronary arteries across varying patient anatomies. Importantly, these design modifications do not compromise the valve's performance, hemodynamics, or radial strength.

Severe aortic stenosis, characterized by stiffened and thickened aortic valve leaflets, significantly impacts patients' quality of life and limits daily activities. Without intervention, it can lead to heart failure, with a mortality rate of up to 50% within two years for symptomatic patients.

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories in the U.S. Early Commercial Experience is scheduled for spring 2024, with a full product launch anticipated in summer 2024.

This FDA approval represents a significant advancement in the treatment of severe aortic stenosis, offering clinicians and patients an innovative solution designed to improve outcomes and enhance patient care.


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