Thoratec Corp. (THOR) announced that U.S. Food and Drug Administration has granted an Investigational Device Exemption to commence the REVIVE-IT study utilizing the HeartMate II Left Ventricular Assist System.
REVIVE-IT or, Randomized Evaluation of VAD InterVEntion before Inotropic Therapy, is a prospective, randomized, controlled trial designed to compare the use of the HeartMate II LVAD with optimal medical management in patients with New York Heart Association Class III heart failure. The 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.
The REVIVE-IT pilot study is designed to enroll up to 100 patients in NYHA Class III heart failure from leading heart failure programs across the U.S. The primary endpoint for the study is a composite measure of survival, freedom from disabling stroke, and improvement in functional outcomes, as measured by the six-minute walk test.
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