The U.S. Food and Drug Administration (FDA) yesterday approved the AbioCor®, the world’s first completely self-contained, implantable Replacement Heart.
This approval provides patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative, a viable option for extending the quality of their life.
“This device represents a significant advance in artificial heart technology and holds promise for critically ill heart patients who are not candidates for heart transplants due to age or other medical conditions,” said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. “We hope today’s approval will encourage the continued development of potentially life-saving technologies for critically ill patients.”
The quest for an implantable artificial heart began in 1964 at the National Heart Institute (NHI), now the National Heart, Lung and Blood Institute (NHLBI). The goal was to create an Artificial Heart Program aimed at reducing death and disability from heart disease through the development of reliable cardiac assist and total replacement heart systems.
The AbioCor is intended to replace the severely damaged native heart for patients who are not eligible for a transplant and have no other treatment alternative. The AbioCor sustains the body’s circulatory system and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. A post-market study is planned to allow Abiomed to monitor and optimize the introduction of the AbioCor into clinical use.
FDA based approval on the company’s laboratory and animal testing and on a small clinical study of 14 patients conducted by Abiomed. The study showed that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available. In some cases the device extended survival by several months, allowing the patients to spend valuable time with family and friends. In two cases, the device extended survival by 10 and 17 months respectively, and one patient was discharged from the hospital to go home.
AbioCor will be available under a Humanitarian Use Device (HUD) provisions and will be limited to a patient population in the United States under this approval, with no more than 4,000 patients receiving the technology each year. In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program which may take six to eight months. Under HDE approval, the FDA may request a panel review of the post-approval study data.
AbioMed, maker of the Replacement Heart, will reportedly charge $250,000 for the device.
FDA’s approval of the First Implantable Replacement Heart marks the realization of a goal 25 years in the making.