THE WOODLANDS, Texas & BERLIN–(BUSINESS WIRE)–The Berlin Heart Group
announced today that clinical trial data were presented this morning at the “Scientific
Sessions 2011” annual meeting of the American Heart Association (AHA). These
data showed that, in a clinical trial of children with severe heart failure who
were waiting for a heart transplant, 90% of patients in the primary cohort of
the study were successfully bridged to a heart transplant using Berlin Hearts EXCOR® Pediatric Ventricular Assist Device
(VAD).
On July 21, 2011, the Circulatory Systems Devices Advisory
Panel recommended that the FDA grant “Humanitarian Device Exemption” (HDE)
approval of the Berlin Heart EXCOR® Pediatric VAD: “…there is a definite
benefit of this (EXCOR®) device to support critically ill children awaiting
heart transplantation.” The Berlin Heart EXCOR® Pediatric VAD is a
mechanical cardiac support system for critically ill pediatric patients
suffering from severe heart failure. The system is designed to support
pediatric patients of all age groups, from newborns to teenagers, and is
intended to bridge patients awaiting heart transplantation from days up to
several months, until a donor heart becomes available. The Berlin Heart EXCOR®
Pediatric VAD, which is approved for use in Europe and Canada, is the only Ventricular Assist Device
that is designed specifically for the pediatric population to be unanimously
recommended for approval in the United
States.
“This was a landmark clinical study of children suffering
from end-stage heart disease,” said Christopher S. D. Almond, M.D., Department
of Cardiology, Childrens Hospital Boston, the primary pediatric teaching
hospital of Harvard
Medical School,
and co-principal investigator of the EXCOR® clinical trial. “Based on these
data, the advisory panel has recommended that the FDA grant approval of the
EXCOR® pediatric VAD, which would mean that the medical community would be able
to offer a lifesaving alternative to severely ill children who would not likely
survive while waiting for a heart transplant. EXCOR® will usher in a new era
for treating children with end-stage heart disease.”
“I am extremely gratified to have led the study on the EXCOR®
Pediatric VAD,” said Charles D. Fraser, Jr., M.D., surgeon-in-chief at Texas
Childrens Hospital, professor of surgery and pediatrics at Baylor College of
Medicine and national principal investigator for the North American Berlin
Heart EXCOR® Pediatric study. “Our findings show that babies and children with
terminal heart failure can be treated with the EXCOR® with good results. We
hope that the medical community will soon be able to offer this life-saving
device to support desperate children who would not otherwise survive while
awaiting donor hearts. The study involved an incredible effort from 15 U.S. hospitals
and two Canadian centers with extensive experience in pediatric heart failure
and transplantation. It should serve as a model for future collaborative device
studies involving children, industry, medicine and the FDA.”
“The successful conclusion of the EXCOR® clinical trial
bears strong testimony to the close collaboration of the FDA with Berlin Heart
to design a meaningful study with useful conclusions,” added Bob Kroslowitz,
President and CEO of Berlin Hearts North American operations. “Indeed, this
study reflects the FDAs efforts to encourage the medtech industry to develop
heart and other devices for kids, who typically comprise too small a market to
whet the commercial appetite of medical device companies.”
About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces, and
distributes implantable and external ventricular assist devices (VADs) for
patients of every age and body size. The company offers pumps, cannulas, and
external components for internal and external use to stabilize cardiac activity
in acutely ill patients. Its products are market leaders in their respective
segments in Germany and in Europe. The company also manufactures the implantable
left ventricular assist device INCOR®, which has been designed for long-term
application in adult patients. The longest the device has supported a patient
to date is more than five years and ongoing. INCOR® is not FDA-approved, but
widely used in Europe.
Berlin Heart Inc., the companys US subsidiary, was founded in 2005
to support the North American centers. Further information is available from
the company website: www.berlinheart.com.
CAUTION: The Berlin Heart EXCOR® Pediatric Ventricular
Assist Device (VAD) is an investigational device limited by federal (United States)
law to investigational use only. EXCOR® is approved for use in Canada and Europe.
