Berlin Heart Receives First Regulatory Approval in North America



    
    Berlin Heart Receives its First Marketing Approval in North America for
    the EXCOR(R) Pediatric Ventricular Assist Device for Children
    

    BERLIN, April 3 /CNW/ - Berlin Heart GmbH today announced it has received
its first marketing approval in North America. The EXCOR(R) Pediatric
ventricular assist device received the License with Conditions from Health
Canada, the Federal Department responsible for regulatory issues in Canada.
    The Berlin Heart EXCOR Pediatric is a mechanical cardiac support system
for critically ill pediatric patients suffering from severe heart failure.
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.
    Dr. Johannes Muller, General Manager of Berlin Heart, comments: "The
license with conditions represents a milestone reached for children and
teenagers suffering from severe heart failure, as the system is now more
readily available in Canada. Since patients often require acute emergency
support, this is a major step toward improved care for these potentially
terminally ill children."
    Since the application for Canadian regulatory approval in September 2007,
21 patients were supported in Canada with EXCOR Pediatric under special access
approval.

    About EXCOR(R) Pediatric

    EXCOR Pediatric is a pulsatile, pneumatically driven ventricular assist
device and can be used to support one or both ventricles. EXCOR Pediatric has
been used in more than 500 pediatric patients worldwide ranging from newborns
with 2.2 kg body weight to teenagers. Since the first application of the
ventricular assist device in Canada in July 2002, 39 children and teenagers
have been supported with EXCOR Pediatric. EXCOR is currently under clinical
investigation for pediatric patients in USA.

    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. The company is market leader in Germany and
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 and a half years and ongoing. INCOR is not FDA approved, but widely used
in Europe.




For further information:

For further information: Linda Buerk, Manager Marketing & PR, Phone:
+49(0)30-8187-2650, Mobile: +49(0)173-629-0803, buerk@berlinheart.de

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BERLIN HEART GMBH

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