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.
"IDE approval represents a significant milestone for REVIVE-IT, and we are excited to move forward with this important study, which will allow us to examine the use of LVAD technology earlier in the spectrum of heart failure," said Keith Aaronson , M.D., M.S., medical director of the heart transplant program and Center for Circulatory Support at the University of Michigan Cardiovascular Center (UM-CVC). Aaronson is serving as a co-principal investigator for REVIVE-IT, along with Francis D. Pagani , M.D., Ph.D., surgical director of the heart transplant program and Center for Circulatory Support at the UM-CVC, to whom the REVIVE-IT IDE was issued, and Robert Kormos , M.D., director of the University of Pittsburgh Medical Center (UPMC) Artificial Heart Program and co-director of the UPMC Heart Transplantation Program.
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. Patients will receive either the HeartMate II LVAD or OMM (drug therapy). 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.
"REVIVE-IT will evaluate the use of the HeartMate II in heart failure patients currently not indicated for LVAD support. These patients suffer from highly impaired quality of life and functional capacity, but their disease has not yet advanced to the point of more serious consequences, such as organ damage or immobility," stated Dr. Kormos from UPMC.
The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and Thoratec are sponsoring the REVIVE-IT study, through a $5 million contract from the NHLBI and a funding commitment of up to $11 million from Thoratec. The NHLBI is providing executive and scientific guidance on the conduct of the study.
"We appreciate the leadership demonstrated by the NHLBI in this pioneering study, as well as our partnership with Thoratec," said Dr. Pagani. "The HeartMate II device has been extensively studied for long-term support of advanced heart failure patients and has a very well-defined efficacy and safety profile. We look forward to exploring its utilization and potential benefits, including extended survival and improved functional status, in earlier-stage patients."
In addition to REVIVE-IT, Thoratec maintains a firm commitment to the completion of the ongoing ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) study. "ROADMAP and REVIVE-IT are complementary studies which together should advance the field's understanding of LVAD therapy in Class III and earlier-stage Class IV heart failure patients," stated David Farrar , Ph.D., Vice President, Research and Scientific Affairs at Thoratec. ROADMAP is a post-market study of the HeartMate II, involving ambulatory advanced heart failure patients who are not yet dependent on intravenous inotropic support and are typically categorized as INTERMACS profiles 4-6, within the existing FDA-approved indication for Destination Therapy, whereas REVIVE-IT will include Class III patients currently not approved for LVAD support. As of the end of 2012, 90 patients have been enrolled in ROADMAP, and Thoratec expects the full cohort of 200 patients to be enrolled by the end of 2013.
"Thoratec's mission is to advance the treatment of heart failure and the field of mechanical circulatory support. To that end, we are pleased to partner with preeminent VAD programs across the U.S., under the leadership of the UM-CVC and UPMC, in the REVIVE-IT study," commented Gary F. Burbach , President and Chief Executive Officer of Thoratec.