HHS NEWS

U.S. Department of Health and Human Services

P98-28                          FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE           Sharon Snider:       301-827-6242
September 29, 1998              
                                Consumer Inquiries:  800-532-4440

FDA APPROVES TWO PORTABLE HEART-ASSIST DEVICES

FDA today approved two portable heart assist devices--the first of their kind--that will support patients outside the hospital while they await heart transplants. The devices help do the heart's work by pumping blood through the body until a donor heart is available for transplantation.

The products are the HeartMate Vented Electric Left Ventricular Assist System, made by Thermo Cardiosystems Inc. of Woburn, Mass., and Novacor LVAS, made by Baxter Healthcare Corporation, Oakland, Calif. A slightly different version of the HeartMate was approved for use in hospitals in 1994.

"Until now, patients on a heart-assist device had to stay in the hospital connected to a console which powered the pump, or they occasionally could go home with extensive home healthcare support. These new devices allow patients far more freedom outside the hospital and have the potential to improve the quality of their lives," said FDA Acting Commissioner Michael A. Friedman, M.D.

The new, portable products are similar. They consist of a blood pump implanted in the abdominal area connected by a cable through the skin to a small external computer worn at the waist. The computer can be powered by a base unit that is plugged into the wall or by batteries worn at the waist or, in the case of the HeartMate product, under the arms.

The pump is connected to the left ventricle, the main pumping chanber of the heart. From there, blood is pumped by the HeartMate or Novacor LVAS into the main artery supplying blood to the body. Patients who recover sufficiently from having the pumps implanted (in about two to three weeks) may be healthy enough to leave the hospital while waiting for a suitable donor heart.

FDA's approval of these devices is based on a review of safety and effectiveness data submitted by the manufacturers. The firms each studied their device in patients inside and outside the hospital, who were transplant candidates at risk of imminent death. The studies showed that the heart-assist devices worked equally well inside and outside the hospital in supporting patients until a donor heart could be found.

Although patients with the new heart-assist devices may live outside the hospital, they need to be near a hospital or heart transplant center that knows how to manage the devices. In addition, patients must be trained to understand and use the system before they can leave the hospital.

The heart-assist systems are approved for use in patients with irreversible heart failure when their condition is deteriorating so rapidly they are likely to die in 24 to 48 hours. In addition, the patients must be on their hospital's transplant list in order to qualify for one of these devices.

An estimated 15,000 to 20,000 peopple in the United States are potential candidates for heart transplants each year, but there are only enough hearts for about 2,000 people. Some patients currently waiting for a heart transplant could be candidates for heart-assist devices. The new, portable devices are expected to be available immediately.

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