Clinical Trials Information
The Food and Drug Administration approved the first series of U.S. clinical trials for the Arrow LionHeart™ heart assist device in February 2001. Penn State Milton S. Hershey Medical Center implanted the device in the first U.S. patient later that month. This device, the first heart assist device powered by wireless electric transmission to reach clinical trial, was developed by Penn State College of Medicine researchers in conjunction with Arrow International, Inc. of Reading, PA.
Walter E. Pae Jr., M.D., a surgeon at Penn State Milton S. Hershey Medical Center, is the principal investigator for the clinical trials, which are sponsored by Arrow. In addition to Penn State Hershey Medical Center, five other sites are taking part in the trials: University of Pennsylvania, University of Arizona, University of Iowa, and Columbia University, Washington Hospital Center. The first set of clinical trials included seven patients and was completed in 2002.
The FDA approved a second set of clinical trials in February 2001. For this second set of seven patients, the FDA altered the inclusion criteria to allow for patients with heart failure with fewer or less severe pre-surgical medical complications, but who stood only a 50 percent chance of living more then six months. The criteria for the first seven patients allowed only those whose chances of operative complications were very high.
The European clinical trials of the Arrow LionHeart™, conducted under the medical supervision of principal investigator Walter E. Pae Jr., M.D., surgeon at Penn State Milton S. Hershey Medical Center, recently were completed. A total of 26 European patients received the implant.
Arrow, also the sponsor for the European trials, submitted the clinical data to the European Notified Body, TUV Product Service, with the goal of attaining the CE-Mark, a “stamp” of approval, similar to FDA approval in the United States, that would allow the company to make the device available to physicians as a treatment option for patients with end-stage heart failure.
The first-ever human implant of the LionHeart™ left ventricular assist system took place Oct. 26, 1999 at the Hearzzentrum NRW in Bad Oeynhausen, Germany. Eight patients have lived with the device for more than one year, and four patients have lived with the device for more than two years.
The clinical sites for the European clinical investigation were: Herzzentrum NRW, Bad Oeynhausen, Germany; Hospital La Pitié, Paris, France; University of Jena, Jena, Germany; University of Vienna Hospital, Vienna, Austria; Berlin Heart Institute, Berlin, Germany; Province Hospital of Basel, Basel, Switzerland; San Mateo Polyclinic, Pavia, Italy; CHUV Hospital Vaudois, Lausanne, Switzerland.