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.