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Berlin Heart Receives First Regulatory Approval in North America

BERLIN, April 3 /PRNewswire/ -- 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.

    Linda Buerk
    Manager Marketing & PR
    Phone: +49(0)30-8187-2650
    Mobile: +49(0)173-629-0803

SOURCE Berlin Heart GmbH
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