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Thoratec Corp Announces FDA Approval To Commence REVIVE-IT Study Utilizing HeartMate II


Monday, 7 Jan 2013 08:30am EST 

Thoratec Corp announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilizing the HeartMate II Left Ventricular Assist System. REVIVE-IT ( Randomized E valuation of V AD I nter VE ntion before I notropic T herapy) is a prospective, randomized, controlled trial designed to compare the use of the HeartMate II LVAD with optimal medical management (OMM) in patients with New York Heart Association (NYHA) Class III heart failure. This feasibility study is intended to provide initial scientific evidence regarding the potential advantages of MCS therapy in treating earlier-stage, less ill heart failure patients who are currently not indicated for LVAD support. 

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19 Sep 2014