Medtronic Plc: FDA Approves Evolut FX+ TAVR System - Quick Facts

(RTTNews) - Medtronic plc (MDT) announced the FDA has approved the Evolut FX+ transcatheter aortic valve replacement system for the treatment of symptomatic severe aortic stenosis. The latest system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

The company said Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories in the U.S. Early commercial experience is planned for spring 2024 with full product launch expected in summer 2024.

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