07 Jan 2019

MEDTRONIC GETS OK TO STUDY PATIENTS WITH BICUSPID AORTIC VALUES USING COREVALVE EVOLUT TAVR SYSTEM

The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for Medtronic to initiate a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. Medtronic separately received FDA approval for revised commercial

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