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September 30, 1993
Hershey Awarded New Contract to Develop Artificial Heart

Hershey, Pa -- Penn State's Milton S. Hershey Medical Center is one of only three institutions to be awarded a three-year, $5.4 million contract from the national Heart, Lung and Blood Institute to continue its work in developing a permanently implantable electric artificial heart.

At the end of the three-year contract period (known as Phase I), the NHLBI will embark on a second phase of support. Based on the progress made in the first phase, Penn State's Hershey Medical Center is eligible to receive funding for an additional four years bringing the total award to $13.9 million over seven years.

"The contract will allow us to complete our animal studies and refine our current (artificial heart) model" says principal investigator Gerson Rosenberg, Ph.D., research professor of surgery and Chief of the Division of Artificial Organs.

"We're obviously very pleased that the NHLBI decided to continue the contract for this work," he says. The new contract comes on the heels of a five-and-a-half year, $5.8 million contract that ends this month.

"Our track record with developing the artificial heart and mechanical circulatory assist devices-work which began in 1970, combined with our brand new state-of- the-art Biomedical Research Building, made us strong competitors for obtaining contract support," says William Pierce, M.D., professor of surgery and Chief of the Division of Cardiothoracic Surgery. "This ability to obtain funding ensures that the Medical Center will play a leadership role in this field into the 21st century."

The contract, "Phased readiness Testing of Implantable Total Artificial Heart," which includes a subcontract with 3M/Sarns for approximately $8.1 million, is the largest research award the Medical Center has ever received.

"The purpose of the original work has been to develop a completely implantable total electric artificial heart that would allow a patient to lead a relatively normal lifestyle," Rosenberg says. "We already have a complete system-we achieved that goal in this past contrast," he notes, adding that prototypes have already been implanted in 18 calves, several of which have lived more that 100 days with the device. Rosenberg says the Penn State team's goal is to develop a wireless electric total artificial heart that will last for five years, which would compete favorably with the survival time for heart transplant patients.

The goal of the new contract, he says, is to complete the studies by the year 2000 and then apply for permission from the Food and Drug Administration to begin human clinical trials."

The air-driven Penn State Heart is one of only two artificial hearts approved by the FDA for use in humans as a temporary bridge to a heart transplant.

According to Rosenberg, both laboratory and animal testing will continue. Before human clinical trials become a reality, he and his research group will have to run the electric heart through its paces, beginning with long-term testing on a mock circulatory system that was used to verify the operation of the device before it was implanted in animals. This" readiness testing" entails testing the heart as if it was pumping inside a person's chest.

The heart is powered by a battery kept near the recipient. Energy is transmitted from the battery across the intact skin by a pair of wire coils. A four-inch-diameter coil lays on the skin and transmits energy to a smaller coil implanted under the skin. This energy is used by an implanted electronic control system to power the small electric motor that provides the force for the blood pump, A battery, housed in the same container as the electronics, provides about 30 minutes of operation when the external coil is removed.

"We will build a second-generation electric total artificial heart, which will have a number of system refinements," he explains. Some of the changes will likely involve the external battery pack. "Specifically, we'll look at whether it is a comfortable, user-friendly system. We'll also look at whether we can make improvements in the telemetry and energy transmission systems, or other electronic refinements, taking advantage of the latest electronics," he notes.

Persons implanted with such a device would carry the 10-ppound, eight-hour battery pack over the shoulder.

"we've learned a great deal since we began the last contract five years ago." Rosenberg says. "Now we have a completely implantable system. The progress has been outstanding; I'm very proud we've met our goals to date."

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PENN STATE -- HERSHEY MEDICAL CENTER
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