Dr. Stefan Thamasett, CEO of the Berlin Heart Group, commented, "The Panel's unanimous decision represents another major milestone for the Berlin Heart Group in bringing this important lifesaving technology to the pediatric population. Completing this historical, first ever prospective controlled clinical trail for Ventricular Assist Devices in children is a major achievement for both Berlin Heart and the Medical Community."
While Berlin Heart awaits the final decision of the FDA, Implants of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device in the US for BTT patients are continuing under a Continued Access Protocol approved by the FDA.
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, cannulae, and external components for internal and external use to stabilize 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®, 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:
Berlin Heart Inc.
|SOURCE Berlin Heart GmbH|
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