Medtronic receives FDA approval for its new-generation Evolut FX+ TAVR system for treating severe aortic stenosis.
Medtronic announces FDA approval of its newest-generation Evolut FX+ TAVR system for treating symptomatic severe aortic stenosis. The device maintains the valve performance of its predecessor and adds larger windows to aid in coronary access. The Evolut FX+ TAVR system is indicated for all risk categories and is planned for early commercial experience in Spring 2024, with a full product launch expected in Summer 2024.
March 27, 2024
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