The FDA finally gave a green light for the world’s first completely self-contained, implantable artificial heart. Abiomed Inc. announced that it has received Humanitarian Device Exemption approval from the FDA for its AbioCor Implantable Replacement Heart:
“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 AbioCor system consists of: a two-pound mechanical heart that takes over the pumping function of the diseased heart, which is removed during the implantation procedure; a power transfer coil that powers the system across the skin and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the patient’s abdomen. The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to one hour. The system also includes two external batteries that allow free movement for up to two hours. During sleep and while batteries are being recharged, the system can be plugged into an electrical outlet.
In order to receive the artificial heart, in addition to meeting other criteria, patients must undergo a screening process to determine if their chest volume is large enough to hold the device.