Heart assist device company Thoratec Corporation has announced that the U.S. FDA has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilising the HeartMate II® Left Ventricular Assist System. The study outcome may result in a broadening of indications for mechanical circulatory support. The logic seems to be that many patients will ultimately require it in the fullness of time, so why wait until they meet the indication criteria when quality of life and other measure may benefit from earlier application.
Thoratec’s HeartMate II is the only continuous-flow left ventricular assist device (LVAD) approved by the FDA for both Bridge to Transplantation and Destination Therapy. The device is designed to provide long-term cardiac support, pumping up to 10 litres of blood per minute for full support of the circulation, or to supplement the native function of the patient’s left ventricle.
More than 200 peer-reviewed publications have featured studies regarding the HeartMate II, far exceeding the volume of published data on all other LVADs combined. To date, over 13,000 patients have been implanted with the HeartMate II, including over 5,500 currently on support.
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.
REVIVE-IT (Randomized Evaluation of VAD InterVEntion before Inotropic Therapy) is a prospective, randomised, 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 so-called Mechanical Circulatory Support (MCS) therapy in treating earlier-stage, less ill heart failure patients who are not currently indicated for LVAD. Thoratec will therefore be hoping for a positive outcome in order to increase it’s potential market.
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.
“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.
“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.
“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.
Source: Thoratec, Inc., PR Newswire