Thoratec Corporation 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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