Berlin Heart GmbH
Berlin Heart Receives First Regulatory Approval in North America
Published in Medical Device Law Weekly, April 19th, 2009
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...
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