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FDA Updates

FDA approves TAVR System in severe AS

By August 25, 2021No Comments

The US Food and Drug Administration has approved Medtronic’s Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all risk levels. The Evolut FX system features a self-expanding, supra-annular valve and is designed to enhance ease-of-use and provide greater precision and control throughout the procedure. The fourth-generation device is equipped with gold markers built into the frame to provide direct visualization of depth and valve leaflet location during implant.

Source: Medscape

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