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June 24, 2003
Lionheart Recipient at Penn State
Hershey Medical Center First U.S.
Patient to Head Home with Device

Implant marks second procedure in the revised Phase I U.S. clinical trials

HERSHEY, PA On Tuesday, May 14, 2003, surgeon Walter E. Pae, Jr., M.D., implanted an Arrow LionHeart left ventricular assist device (LVAD) in a 35-year-old man from York, Pa. Today, that patient, Gayle Snider is officially going home. This marks the first time a U.S. recipient of the totally implantable heart-assist device conceived of and developed at Penn State College of Medicine in conjunction with Arrow International, Reading, Pa., has been released from the hospital. The procedure also marks the second procedure in the second set of U.S. human trials.

"The patient is doing extremely well, so well in fact, that we feel he's ready to go home," said Walter E. Pae, Jr., M.D., surgeon, Penn State Milton S. Hershey Medical Center, and principal investigator for the study. "We will continue to closely monitor his progress. Through implantation of the Arrow LionHeart , we hope to lengthen Gayle's life and improve his overall quality of life."

The LionHeart medical and research team and Snider participated in a news conference today to announce this latest success.

"I am feeling great - better than I ever expected," Snider said. "It's just phenomenal. I can't believe after 40 days I'm going home. I'm looking forward to getting back to a daily routine, most of all, sleeping in my own bed. I hope that my decision to go with the Arrow LionHeart will help others in the future."

The Arrow LionHeart is intended as a long-term therapy for patients with end-stage heart failure who are not candidates for heart transplantation. Nearly 5 million Americans have heart failure and an estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year. Only a fraction of those are eligible for and receive heart transplants. Such patients have a poor quality of life and low probability of surviving six months.

"The exciting part about this new phase of the study is that the FDA altered the inclusion criteria to allow for patients who were not at death's doorstep, but only had a 50-50 chance of living six months," said John P. Boehmer, M.D., cardiologist, Penn State Cardiovascular Center, Penn State Milton S. Hershey Medical Center. "The criteria for the first seven patients allowed only patients whose chances of operative complications were certain."

Boehmer said that Snider can expect regular visits to the medical center for checkups.

"We will be seeing him weekly at first, then every other week then, at most, monthly," Boehmer said. "Gayle will take medicines mainly to thin his blood and to control some fluid retention."

The Arrow LionHeart is capable of taking over the entire workload of the left ventricle. It is totally implanted and energy from an external battery pack is transmitted across the intact skin to power the system and charge the implanted battery. A similar device has been shown in clinical trials to lengthen and improve the lives of people such as Gayle. However, long-term benefit was limited by infection of cables protruding through the skin or failure of the device motor. The hope is that the advances with the LionHeart will help to eliminate these complications and further improve and lengthen the lives of people with end-stage heart disease.

"There are no external lines or cables protruding through the skin," Pae said. "This alone offers significant advantage to the patient because tubes or wires used in other heart assist devices can be a conduit for infection. Because there is nothing through the skin, it also allows patients to detach from the power source for short periods to bathe or swim."

The surgery involves attaching a mechanical circulatory assist device to the patient's natural heart. At the beginning of the procedure, the surgeon creates pockets in the abdominal and chest walls to hold the blood pump assembly, the energy source to power the moisture-proof 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 tubes are placed to connect the patient's heart and main blood vessel to the pump. Electrical connections are made from the pump and internal coil to the internal motor controller. Once the LVAD 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 turned on takes over operation of the patient's left ventricle creating a physiologically normal pumping heart.

In February 2001, Arrow announced that the device received FDA approval under the Investigational Device Exemption to begin Phase I human clinical trials. The first U.S. recipient of the LionHeart received the device on February 28, 2001, at Penn State Milton S. Hershey Medical Center. On July 26, Penn State Hershey Medical Center reported that the first U.S. patient died.

Clinical trials have been underway in Europe for nearly four years and are near completion. In the European trials, eight patients lived with the device for more than one year, and five patients lived with the device for more than two years.

Penn State College of Medicine has a long history of heart device development dating to the 1970s when William S. Pierce, M.D., started his groundbreaking research in artificial organ development.

The technology behind Arrow LionHeart was developed by Penn State Milton S. Hershey Medical Center's multidisciplinary team from the Division of Artificial Organs led by Gerson Rosenberg, Ph.D., Design News 2002 Engineer of the Year.

This is the first heart assist device to reach clinical trial that is powered by wireless electric transmission. This allows the system to be totally implantable, giving patients freedom to take part in a broader range of activities and live an improved quality of life.

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PENN STATE -- HERSHEY MEDICAL CENTER
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