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Dr. Charles D. Fraser discusses FDA approval of Berlin Heart for babies and children

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Uploaded on Oct 28, 2011

Texas Children's Hospital, 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 U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption approval for the Berlin Heart EXCOR to be used in U.S. children as a bridge to heart transplantation. Dr. Charles D. Fraser Jr., Surgeon-in-Chief at Texas Children's Hospital, was selected as the National Principal Investigator for the Berlin Heart EXCOR IDE clinical study.

The Berlin Heart is a tiny heart pump that vibrates rhythmically to assist children who cannot pump enough blood with their own natural heart. Before the Berlin Heart, physicians used complicated medical therapies to treat children with heart failure. Because these therapies provide only short-term support when a child’s heart has failed completely, newborns and children often die waiting for a heart transplant. About only 75 small donor hearts become available each year, so having an effective bridge to heart transplant like the Berlin Heart can help children with heart failure survive until a suitable donor heart is found.

Learn more about the Berlin Heart at Texas Children's Hospital
http://www.texaschildrens.org/Berlin-...

Learn more about Texas Children's Heart Center
http://www.texaschildrens.org/heart/

About Dr. Charles D. Fraser, Surgeon-in-Chief at Texas Children's Hospital
http://www.texaschildrens.org/Locate/...

Berlin Heart Helps a Child Survive until Heart Transplant: Leanny's Story
https://www.youtube.com/watch?v=xx9_7...

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