In addition to the IDE study, Texas Childrens Heart Center has been named the first Berlin Heart Reference and Training Center in the United States offering support to hospitals not participating in the study who seek to use the Berlin Heart for the first time. Dr. David Morales, pediatric cardiovascular surgeon at Texas Childrens and assistant professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will direct a training team comprised of cardiac surgeons, cardiologists, perfusionists, operating room nurses, ICU nurses, research nurses and a designated Berlin Heart Fellow. The team will hold periodic training sessions at Texas Children's, and they will also travel to other hospitals to provide instruction on-site.
We are delighted to have the exerienced and dedicated team from Texas Childrens Heart Center as our first Reference and Training Center in the U.S., said Robert H. Halfmann, MD, director clinical science at Berlin Heart GmbH, Germany. We are also pleased to work with Dr. Fraser as the NPI for the EXCOR Pediatric IDE trial, which is of great importance to us.
Between 2000 and 2007, prior to FDA approval to begin the study, pediatric hospitals in the U. S. used the Berlin Heart under the FDAs emergency or compassionate use regulations. Each time a physician wanted to implant the Berlin Heart in a child dying of heart failure, a special appeal had to be made to the FDA for approval on a c
|Contact: Carol Wittman|
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Texas Children's Hospital