Berlin Heart Receives First Regulatory Approval in North America


April 27, 2009

April 27, 2009 - Berlin Heart GmbH recently received approval in North America for the EXCOR Pediatric ventricular assist device with a License with Conditions from Health Canada, the federal department responsible for regulatory issues in Canada.

EXCOR is currently under clinical investigation for pediatric patients in the U.S.

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, the company said.

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