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New Heart Assist Device Approved for First U.S. Clinical Trials Arlington, Va., March 27, 2001 – A new wireless heart assist device is the first fully implantable device of its kind to be approved by the Food and Drug Administration to begin clinical trials in the United States. The device, called the Arrow LionHeart™, was developed by biomedical engineers at Pennsylvania State University in conjunction with Arrow International, Inc. of Reading, Penn. Its wireless design should significantly reduce the risk of infection while improving the patient’s mobility and quality of life. The Arrow LionHeart is not an artificial heart. It is a "heart helper" or left ventricle assist system (LVAS) for patients suffering from severe heart failure. The patient's failing heart is connected to it to boost circulation. The LVAS is not intended as a bridge to transplant or as a bridge to recovery of ventricular function, but as a permanent implant for patients who are not eligible for a natural heart transplant. Currently available LVAS devices rely on wires, tubes or other connections that protrude through the skin and increase the risk of infection. The Arrow LionHeart is fully implantable and powered via wireless electric transmission. It is fully automatic and responds to a patient's changing needs, such as during exercise and resting. The new LVAS is based on more than 30 years of research begun by William S. Pierce, M.D., who founded the Penn State artificial organs program. A Penn State design team has coupled his approach with the latest in electronics and biomaterials technology. Members of the team include Gerson Rosenberg, Ph.D., professor of bioengineering, surgery professors Dr. Alan Snyder and Dr. W. J. Weiss at the College of Medicine, as well as materials, energy and fluid flow researchers. The Arrow LionHeart pumps when a metal plate presses on a plastic blood sac, forcing the blood out of the device and back into the patient’s natural circulation. The metal plate is driven by a new miniature electric motor and a controller that reacts to the patient’s blood flow need. The Arrow LionHeart has both internal rechargeable batteries, which remain in the body, and two external battery packs fitted with a unique power delivery coupling. The external battery packs are worn on a belt and power 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 for about 20 minutes before needing to be recharged. The Arrow LionHeart is the result of a 7-year collaboration among researchers at 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. Clinical trials have been proceeding in Europe since October 1999, under the direction of Walter E. Pae, Jr., M.D., Penn State professor of surgery, and Arrow. The LionHeart has been implanted in 10 patients. The longest survivor has had the assist device for nearly a year. The device has not failed in these trials. About 4 million patients in the United States 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," Pae says.
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