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March 25, 1999
Durability Tests Underway for the Penn State Artificial Heart

Hershey, Pa -- A two-year durability test is now underway at Penn State's College of Medicine on the Penn State total electric artificial heart. The durability testing is one of the final steps before the devices could reach human clinical trials.

"We have eight artificial hearts that will operate simultaneously. The goal is to have all of the heart systems run for two years without any problems," explains Alan Snyder, Ph.D., senior research associate at Penn State's College of Medicine.

The electrically powered Penn State heart is totally implantable and is designed to replace the heart rather than as a bridge to transplant. The electricity is supplied to the heart by an electrical coil implant beneath the patient's skin. It is also equipped with backup batteries.

During the durability testing, which began earlier this month, researchers are looking for any signs of wear. "When these tests are complete we will be looking very carefully at the internal parts of the systems," explains Majorie Rawhouser, research assistant.

The eight systems are all submerged in salt water at body temperature in a large fish tank.

The systems pump the water at body temperature, rather than human blood. Computers monitor the systems 24 hours a day, looking for any signs of possible breakdowns.

Rawhouser also explains that all of the data collected over the next two years will be presented to the Food and Drug Administration. She estimates that if all eight hearts work without fail, clinical trials could begin within a year or two after these tests have been completed.

The Penn State artificial heart has been tested extensively in calves, which are used because their chest size is similar to that of humans. Testing in calves, explains Rawhouser, usually only last about three months because the calves grow so quickly and become too big for the artificial heart. The test with calves will continue over the next several years while the durability testing is going on. The animal tests are designed to focus on biological interactions between the heart and the recipient.

"The average heart will beat more than 30 million times per year. Trying to duplicate this is a great challenge," explains Snyder. He estimates that as many as 20,000 people in the United States could benefit each year from the totally artificial heart. The number of human donor hearts has remained at about 2,000 for the past several years.

This work is funded by a contract with the National Heart, Lung and Blood Institute. Penn State is also working with 3M Health Care on the project.

CONTACT:

Leilyn Perri (717) 531-8604 (o) lperri@psu.edu
Steven Bortner (717) 531-8606 (o)

PENN STATE -- HERSHEY MEDICAL CENTER
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