FDA Approves Thoratec REVIVE-IT Study Utilizing HeartMate II
Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support (MCS) therapies to save, support and restore failing hearts, today 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 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 (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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