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March 1, 2001
Penn State Milton S. Hershey Medical Center
Performs First U.S. Implant Of The Arrow Lionheart TM

Hershey, Pa. -- Walter Pae, Jr., M.D., professor of surgery at Penn State College of Medicine and director of transplantation at Penn State Milton S. Hershey Medical Center, successfully implanted the Arrow LionHeartTM left ventricular assist system (LVAS) for the first time in the United States yesterday (Feb 28).

The surgery, which took place at the Penn State Milton S. Hershey Medical Center, lasted five hours. The patient is in critical condition and recovering as expected at the Medical Center. The Arrow LionHeart TM, which is capable of taking over the entire work load of the left ventricle, received approval from the U. S. Food and Drug Administration for clinical testing in the United States less than one month ago. The system has been undergoing clinical trials in Europe for the past nineteen months. Pae led the surgical team that performed the first implant of the LVAS at the German Heart Center in Bad Oeynhausen, Germany on a 67-year-old male. The patient is at home and doing well.

The Arrow Lionheart TM is intended as final therapy for patients with end-stage heart failure who are not candidates for heart transplantation. Today's LVAS recipient fits those criteria. According to Pae, such patients have an extremely poor quality of life and a low probability of surviving six months.

"Through implantation of the Arrow LionHeartTM system we hope to lengthen the lives of these patients and permit a desirable quality of life," says Pae.

The Arrow LionHeart TM marks a significant advancement in mechanical circulatory support technology because the system is totally implanted. Energy from an external battery pack is transmitted across intact skin to power the system and charge an implanted battery.

"The transcutaneous (across the skin) power source means that there are no external lines or cables protruding through the skin. This alone offers significant advantage to the patient because the percutaneous (through the skin) tubes or wires used in other systems presents a significant risk of infection," says Pae.

"Arrow LionHeart TM recipients have a better quality of life and are more mobile because of this system," he added.

The Arrow LionHeart TM provides therapy for critically ill patients considered ineligible for heart transplantation because of age or other significant medical problems such as diabetes.

"I expect this will help thousands of people around the world," he says.

About 4 million patients in the U.S. are victims of heart failure and nearly 400,000 new cases are diagnosed each year. Of those patients, only about 2,800 receive heart transplants.

"Our patient meets all the criteria for this groundbreaking surgery," says John Boehmer, M.D., the patient's cardiologist. "In addition to meeting the medical criteria, a patient must have a positive attitude, a solid support system, and be motivated to follow medication and therapy regimens following surgery. The patient also must understand the operation of the battery pack and take care to keep the apparatus charged. Although all Arrow LionHeart TM candidates are extremely ill, patients selected for surgery must be strong enough to tolerate the operation."

Pae explains, "The surgery involves attaching a mechanical circulatory assist device to the patient's natural heart. At the beginning of the implant procedure, the surgeon creates pockets in the abdominal and chest walls to hold the blood pump assembly, transcutaneous energy source (an internal coil) to power the hermetic (protected against moisture) motor, motor controller and internal batteries. Then, the patient is placed on a heart-lung machine to keep blood circulating and oxygenated during the surgery and cannulae (tubes) are placed to connect the patient's heart and main blood vessel (aorta) to the pump. Electrical connections are made from the pump and internal coil to the internal motor controller. Once the LVAS is implanted, telemetry is used to monitor the unit. The rate of the pump is increased until the patient can be weaned from the heart-lung machine. The automatic control system is switched on and the pump completely takes over operation of the patient's left ventricle creating a physiologically normal pumping heart.

"Although the risks are similar to those typically associated with any complex heart surgery infection, bleeding, an irregular heartbeat, stroke, and major organ failure, the operative risks are much higher because the patients are older and sicker," he adds.

The technology used in the Arrow LionHeart TM was developed at Penn State during a period of more than 20 years. The Arrow LionHeart TM was developed by a team at Penn State's College of Medicine and Arrow International, Inc. of Reading, Pa.

Penn State College of Medicine is located on the Penn State Milton S. Hershey Medical Center campus in Hershey, Pa. The services of this academic medical facility range from clinical care through its more than 500 affiliated physicians and 11 University Physician Group sites that offer primary, specialty and subspecialty care to complex, high-end tertiary services at the Medical Center.

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EDITORS: Regular news updates, background information, photos and video are posted at http://www.psu.edu/ur/heartdevices/ or at http://www.hmc.psu.edu/lionheart

Contacts:

Mindy Kelchner
College of Medicine/Hershey Medical Center
717-531-8606
A'ndrea Messer
Public Information
814-865-9481-o 814-867-1774 (h) aem1@psu.edu
Vicki Fong
Public Information
814-865-9481-o 814-238-1221 (h) vfong@psu.edu

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