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October 26, 1999
New Heart Assist Device Designed as Permanent Implant For End-Stage Heart Failure

Hershey, Pa. -- For the first time physicians today implanted a new kind of heart-assist device to help a seriously ill patient survive. The surgery marked what physicians hope is the start of a device that will greatly increase the chance of survival and quality of life for patients with end- stage heart failure.

"Currently all assist pumps have drive lines or external tethers that stick out from the body. These lines often cause infections. This new device is totally implantable and it is not a bridge-to-transplant or temporary heart helper but rather a permanent therapy for end stage heart failure in patients who are not candidates for heart transplant," explains lead investigator Walter E. Pae, Jr., professor of surgery at Penn State's College of Medicine. "The device will greatly reduce the chance for infection, improve mobility for patients and enhance their quality of life."

The surgery was performed by Dr. Reiner Korfer with the assistance of Pae at Herzentrum Nordrhein-Westflaen hospital in Bad Oeynhausen, Germany. The patient is a 67 year-old male. He is in critical condition but is recovering as expected.

The surgery was performed in Germany, as Pae and others await approval of the Food and Drug Administration (FDA). Widespread clinical trials are expected to begin in the United States following FDA approval, which is expected early next year.

The device is called the Arrow LionheartTM device and was developed at Penn State's College of Medicine in conjunction with Arrow International, Inc. of Reading, Pa.

Transcutaneous energy transferred to implanted batteries allows patients to be "untethered" for approximately 30 minutes. The current percutaneous drive lines and external tethers are eliminated through the use of a transcutaneous energy transmission system. This represents a significant advance in mechanical circulatory assist technology. The power transmitter/coil (PT) transfers power across the intact skin. The PT is connected to the power pack in normal operation and will likely be worn on the belt or in a pack. The power pack with battery packs provides power to the system. The power pack weighs approximately 8 pounds when loaded with two battery packs. The rechargeable battery packs each provide approximately 2 3 hours of power for mobile operation. The power pack will be worn either with a shoulder harness or in a backpack, or pulled on a handcart.

"This marks a major step forward in heart-assist technology. We think the risk of infection will be greatly reduced, and a device like this will provide a new therapy for patients with end- stage heart failure who with current conventional treatment have a dismal outlook and poor quality of life," explains Pae. "This could help thousands of people around the world."

Pae is expected to return to the U.S. next week. He says that recruitment of investigational sites for the expanded Phase II of the multi-center clinical trial is ongoing.

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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