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September 5, 2006

Media Inquiries:
Heidi Valetkevitch, 301-827-6242
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FDA Approves First Totally Implanted Permanent Artificial Heart for Humanitarian Uses

The U.S. Food and Drug Administration today approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart under the Humanitarian Use Device (HUD) provisions of the Food, Drug and Cosmetic Act. The AbioCor Implantable Replacement Heart, made by Abiomed, Inc. (Danvers, Mass.), 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.

"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.

"The National Heart, Lung, and Blood Institute (NHLBI) is proud to have supported the research which led to this development," said Elizabeth G. Nabel, M.D., Director, NHLBI, National Institutes of Health. "It represents a major technological advance and will benefit people in critical need."

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 was designed to encourage development of innovative medical devices to treat rare conditions. It allows medical devices to be approved for market if they demonstrate safety and probable benefit.

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.

"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," said Schultz. "We believe it is important to make the latest technology available as soon as possible and give patients and families complete information about the risks and benefits so they can make an informed choice."

FDA is requiring the company to provide a comprehensive patient information package to patients and families that clearly describes the risks as well as the probable benefits of the device and explains what patients should expect before, during and after surgery. The patient and physician materials are available on the company's website at www.abiomed.com.

To further refine and improve the use of this artificial heart technology, Abiomed will continue to do additional laboratory studies and will also conduct a post-marketing study of 25 additional patients. The post-market study was recommended by the Circulatory Systems Devices Panel, a part of the agency's Medical Devices Advisory Committee.

For more information on HUDs, visit www.fda.gov/cdrh/ode/guidance/1381.html.


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