Berlin Heart announced today that the FDA has granted "Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD).
The Berlin Heart EXCOR® utilizes the Carmeda Bioactive Surface to improve the blood compatibility of the device and is previously approved for use in Europe and Canada.
The Berlin Heart EXCOR® Pediatric VAD is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system, is designed to support pediatric patients and is intended to bridge patients awaiting heart transplantation until a donor heart becomes available.
To watch a video on the significance of the Berlin Heart EXCOR® device, please see: http://youtu.be/Gj8gM4MignI.