FDA approves U.S. clinical trials for Penn State/Arrow heart assist device

Hershey, PA --- The Food and Drug Administration has approved the first series of U.S. clinical trials for a new kind of heart assist device, called the Arrow LionHeart, developed by Penn State researchers in conjunction with Arrow International, Inc. of Reading, Pa.

The first heart assist device powered via wireless electric transmission to reach clinical trial, the Arrow LionHeart is the result of a seven-year collaboration among researchers affiliated with Penn State's Artificial Organs program and Arrow. Penn State Milton S. Hershey Medical Center is one of the sites in the clinical trials, which are sponsored by Arrow.

The Arrow LionHeart is not an artificial heart. It is a "heart helper" or left ventricle assist system for patients suffering from severe heart failure who are not eligible for a natural heart transplant. The patient's natural failing heart is left in place and the assist device is connected to it to boost circulation. Once the system is implanted in a patient, no wires, tubes or other connections protrude through the skin.

Under the direction of Walter E. Pae, Jr., M.D., Penn State professor of surgery and Arrow, clinical trials have been proceeding in Europe since October 1999. The LionHeart has been implanted in 10 patients. The longest survivor has had the assist device for nearly a year. There have been no device failures.

The new heart assist device is based on an approach originated by Dr. William S. Pierce, who founded the Penn State artificial organs program, coupled with the latest in electronics and biomaterials technology. Penn State members of the design team include Dr. Gerson Rosenberg, professor of bioengineering, Dr. Alan Snyder, associate professor of surgery, and Dr. W. J. Weiss, assistant professor of surgery, at the College of Medicine in Hershey as well as materials, energy and fluid flow researchers at Penn State's University Park campus.

Pumping is achieved in the heart assist device when a metal plate presses on a plastic blood sac, forcing the blood out of the sac. In the Arrow LionHeart, the metal plate is driven by a new miniature electric motor and controller that responds to a patients' changing needs during exercise and resting, for example.

The Arrow LionHeart has both internal rechargeable batteries, which remain in the body, and an external battery pack fitted with a unique power delivery coupling. The external source, two battery packs worn on a belt, powers the motor via a transformer coil worn on the outside of the chest. When the external transformer coil is positioned over an internal transformer coil connected to the motor, it induces a current. The internal and external coils coupled wirelessly through the chest wall maintain the pump's operation. Should the patient want to be untethered from the external battery packs, for example, to take a shower, the internal batteries can supply power needs for a minimum of 20 minutes at a time. In addition, the wireless operation significantly lowers the potential for infection. (For more details, go to www.arrowintl.com)

Dr. Pae notes that about 4 million patients in the U.S. are victims of heart failure and nearly 400,000 new cases are diagnosed each year. Of these patients, only about 2,800 receive heart transplants. "The LionHeart is intended to help this much larger population that is ineligible for transplant and for whom medical therapy has failed," he adds.

Editors: More information, updates and photos are available at www.psu.edu/ur/heartdevices/ on the Internet.

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) [email protected]
Vicki Fong, Public Information, 814-865-9481-o 814-238-1221 (h) [email protected]