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FDA Approves Recapturable TAVR System

Medtronic news release; 2016 Oct 26

The FDA has granted the US approval of the CoreValue Evolut R 34 mm valve (Medtronic plc, Dublin, Ireland), the largest size transcatheter aortic valve replacement (TAVR) system available in the US.

Indication: The Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.

Administration: The Evolut R 34 mm valve is delivered through the En Veo R Delivery Catheter System, which features an InLine Sheath. The Evolut R System is designed to fit within the native aortic valve, using its supra-annular valve positions to help achieve hemodynamic performance.

Citation:

Medtronic announces FDA approval of new recaptureable TAVR system available for severe aortic stenosis patients with large anatomies. [news release]. Dublin, Ireland: Medtronic plc; October 26, 2016: http://phoenix.corporate-ir.net/phoenix.zhtml?c=251324&p=irol-newsArticl.... Accessed November 1, 2016.

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