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Clinical Trials Information
U.S. Trials
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.
European Trials
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 Pitiι, 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. |
