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FDA approves Medtronic’s new TAVR system for aortic stenosis treatment

August 25, 2021

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The US Food and Drug Administration (FDA) has approved Medtronic’s latest self-expanding transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

The Evolut FX TAVR system can offer easy usage as well as increased accuracy and control during procedures and incorporates the hemodynamic, or blood flow, and durability advantages of the Evolut platform.

The device uses the supra-annular valve design that has demonstrated superior haemodynamic performance as against surgical aortic valve replacement (SAVR) in large-scale, randomised clinical trials.

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