The Medtronic CoreValve® System

Medtronic has received FDA approval for the CoreValve® transcatheter valve replacement system. Due to very high rates of survival and some of the lowest rates of stroke and valve leakeage, the FDA granted approval of the CoreValve device without an independent device advisory panel review. Available in sizes ranging from 23mm to 31mm, the self-expanding transcatheter CoreValve® System is designed for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Medtronic received clearance from the EU in May 2013 and CE Markings on August 2011.

(Source: Medtronic)

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