Totally implanted artificial heart

FDA Consumer, Nov-Dec, 2006

Under the Humanitarian Use Device (HUD) provisions of the Food, Drug, and CosmeticAct, the FDA has approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart.

The AbioCor Implantable Replacement Heart, made by Abiomed Inc., Danvers, Mass., was approved in September 2006. It is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. In clinical studies, this product was shown to prolong the life and improve the quality of life 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. There is a power transfer coil that powers the system across the skin and recharges the internal battery from the outside.

A controller and an internal battery 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.

In addition to meeting other criteria, patients must undergo a screening process to determine whether their chest volume is large enough to hold the device before they can receive the artificial heart.

Devices approved under the HUD provisions are those intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States. Similar to the Orphan Drug Act, the HUD provisions were designed to encourage development of innovative medical devices to treat rare conditions. They allow medical devices to be approved for market if they demonstrate safety and probable benefit.

The 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.

"FDA recognizes that not all patients who are eligible will choose this option, but for many patients faced with death, the chance to have additional time with family and friends--however limited--is a chance they are willing to take," says Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. The FDA is requiring the company to provide patients and families a comprehensive patient information package that clearly describes the risks and probable benefits of the device, and explains what patients should expect before, during, and after surgery.