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Texas Children's Hospital, Lead Study Center, Announces U.S. Food and Drug Administration Approval of EXCOR® Pediatric Ventricular Assist Device for Use in United States
Date:12/16/2011

HOUSTON, Dec. 16, 2011 /PRNewswire/ -- Newborns, toddlers and teens who suffer from heart failure and need heart transplantation to survive just got a life-saving pediatric heart pump that buys time and allows them to grow stronger as they wait for a donor heart.

Texas Children's Hospital in Houston, the lead center in a 17-hospital national Investigational Device Exemption (IDE) study on the German-manufactured Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD), announced today that the FDA has granted a Humanitarian Device Exemption (HDE) approval for the EXCOR to be used in U.S. children as a bridge to heart transplantation. To watch a video on the significance of the Berlin Heart, please see: http://youtu.be/Gj8gM4MignI.

The EXCOR, used to provide circulatory support to pediatric patients with severe heart failure, is the only VAD approved in the U.S. for use in babies. The pump allows pediatric patients from newborns to teens to remain active so they grow stronger and meet developmental milestones as they await donor hearts.

"I am extremely gratified that the FDA has granted an HDE approval to the EXCOR Pediatric VAD," said Dr. Charles D. Fraser, Jr., surgeon-in-chief at Texas Children's Hospital, professor of surgery and pediatrics at Baylor College of Medicine and national principal investigator for the North American Berlin Heart EXCOR Pediatric study. "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 an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation. It should serve as a model for future collaborative device studies involving children, industry, medicine and the FDA."

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