BERLIN, Oct. 16 /CNW/ - Berlin Heart Inc. today announced its EXCOR(R)
Pediatric ventricular assist device (VAD) has received unconditional approval
for the ongoing IDE clinical trial in the United States of America. The U.S.
Food and Drug Administration (FDA) has fully approved the Investigational Plan
for the IDE study of the device.
In 2007, the FDA had granted conditional approval for the prospective IDE
study to begin initially at 10 centres with 10 patients, while the company
addressed some questions the FDA had found after reviewing the study design.
"The FDA has worked effectively with Berlin Heart to refine the design of the
trial to optimize the potential for a meaningful study with useful
conclusions," stated Bob Kroslowitz, Vice President of Clinical Affairs for
North America at Berlin Heart.
The Berlin Heart EXCOR Pediatric is a mechanical cardiac support system
for critically ill pediatric patients suffering from severe heart failure.
Unlike standard heart-lung machines, EXCOR Pediatric has been used as a
short-term, mid-term, and long-term support system, supporting failing hearts
from days up to several months.
The system is designed to bridge patients awaiting heart transplantation
until a donor heart becomes available, but has also been used successfully as
a bridge to recovery when a patient's heart was able to recover and work on
its own again. Unlike other VADs, EXCOR Pediatric can be used to support
children of all age groups, from newborns up to teenagers.
Sven-Rene Friedel, the company's CEO, comments, "The FDA's Unconditional
Approval of the IDE study represents a major milestone for the company. The
approval moves us closer to our goal of making the device more readily
available in the US." Bob Kroslowitz adds, "The study is progressing extremely
well and we are confident it will provide positive results. Our next step is
to activate the remaining IDE study sites."
Dr. Charles D. Fraser, Jr., Chief of Congenital Heart Surgery at Texas
Children's Hospital, is the study's Principal Investigator. He commented, "The
device shows exciting promise as a reliable option for children with no hope
who are dying from heart failure. We look forward to bringing the study to
completion and moving device therapies forward in children with heart disease.
The need is great and growing."
The following US centers are participating in the IDE study: Arkansas
Children's Hospital (AR), Boston Children's Hospital (MA), Children's Hospital
of Wisconsin (WI), Lucille Packard Children's Hospital at Stanford (CA), Mott
Children's Hospital (MI), Riley Children's Hospital (IN), Seattle Children's
Hospital (WA), St. Louis Children's Hospital (MO), Texas Children's Hospital
(TX), Children's Hospital at the University of Alabama at Birmingham (AL), and
the University of Minnesota at Fairview (MN).
About EXCOR(R) Pediatric
EXCOR(R) Pediatric is a pulsatile, pneumatically driven ventricular
assist device and can be used to support one or both ventricles. EXCOR(R)
Pediatric has been used in a total of 441 pediatric patients ranging from
newborns with 2 kg body weight to teenagers. The system has been used 174
times in North America; with the FDA granting permission on a compassionate
use basis when the patient was not included in the ongoing IDE study.
About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces,
and distributes implantable and external ventricular assist devices for
patients of every age and body size. The company offers pumps, cannulas, and
external components for internal and external use to stabilise 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(R), which has been designed for long-term application in adult
patients. The longest the device has supported a patient so far is more than
five years and ongoing. INCOR is not FDA-approved, but widely used in Europe.
Berlin Heart Inc., the company's US subsidiary, was founded in 2005 to
support the North American centers. Further product information is available
from the company website: http://www.berlinheart.com.
For further information:
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