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Robert Wood Johnson University Hospital and UMDNJ-Robert Wood Johnson Medical School said Wednesday their surgeons were the first to implant Abiomed's "AbioCor Total Replacement Heart," the first self-contained, implantable artificial heart to win FDA approval.

After extensive training, the surgical team implanted the heart into a 76-year-old male with congestive heart failure. The team's lead surgeon was Mark Anderson, MD, who is associate professor of surgery at UMDNJ-Robert Wood Johnson Medical School and chief of cardiac surgery at the medical school and at Robert Wood Johnson University Hospital.

Made primarily of titanium and blood-safe plastic, the AbioCor is designed so that a patient can remain mobile and continue a productive lifestyle at home. Equipped with an internal motor, the device is able to move blood through the lungs to the rest of the body, while simulating the rhythm of a heartbeat.

The device consists of an internal thoracic unit, an internal rechargeable battery, an internal miniaturized electronics package and an external battery pack.

Dr. Anderson's patient did not qualify for a heart transplant or other available therapies and was diagnosed with severe end-stage heart failure, therefore becoming eligible for the new procedure.

According to FDA, the Abiomed device is intended as a permanent heart replacement for end-stage heart failure patients who are not candidates for transplant and cannot be helped by any other available treatments.

Candidates for the AbioCor system have severe, biventricular, end-stage heart disease but typically have other vital organs that continue to be functioning well.

Generally, patients must be younger than 75 years old, require multiple drugs to increase the strength of contractions of their heart muscle, are not treatable by a mechanical device that assists with the pumping action of the lower left chamber of the heart, and are not weanable from biventricular support if they are on such support.

Although this patient exceeded the FDA-specified age limit by one year, Dr. Anderson said his 76-year old patient's history was unique, allowing him to receive an exemption from FDA so he could have the implant.

The patient will remain anonymous while in the hospital and the hospital said it would not answer inquiries from reporters or others, so the patient can recover quietly.

Robert Wood Johnson University Hospital is one of three centers nationwide approved to perform the AbioCor surgery. Dr. Anderson is one of a handful of physicians nationwide trained to perform the procedure.

"We are honored to be among the few distinguished institutions in the nation to offer this innovative technology to patients who have no other treatment alternatives available to them," Dr. Anderson said.

He added, "The implantation marks the culmination of nearly three decades of research and development and the technology has finally reached the point where an artificial heart has become a real option for end-stage heart failure patients. We believe this procedure is a significant step toward offering new hope and a future to patients who may still have more quality time with their family and loved ones."


Source: Robert Wood Johnson University Hospital