Texas Children's Hospital announces FDA approval of 'Berlin Heart' for kids
The U. S. Food and Drug Administration has approved the use in the United States of the German-manufactured Berlin Heart EXCOR Pediatric Ventricular Assist Device.
The device will be used for newborns, toddlers and teens suffering from heart failure and in need of a heart transplant to survive. The device allows them to grow stronger while waiting for a donor heart.
A 17-hospital national Investigational Device Exemption study, led by Texas Children’s Hospital in Houston, determined that the “Berlin Heart” helps provide circulatory support to pediatric patients and help them remain active in order to grow stronger to allow them to meet important developmental milestones.
“I am extremely gratified that the FDA has granted an HDE approval to the EXCOR Pediatric VAD,” said Dr. Charles D. Fraser Jr., the national principal investigator for the North American Berlin Heart EXCOR Pediatric study, in a press release. “This ushers in a new era for children with terminal heart failure. The medical community is now able to offer this life-saving device to support desperate children who would not otherwise survive while awaiting donor hearts.”
The study involved efforts from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation.
Texas Children’s Heart Center implanted its first Berlin Heart on Sept. 27, 2005.
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