Pediatrics
National study will look at German-made heart pump for children needing heart transplants
Published in Medical Letter on the CDC and FDA, February 10th, 2008
Jan.18, 2008 --Texas Children’s Hospital has been named the national lead center for a 12-hospital, 36-month clinical trial of the German-manufactured pediatric heart pump called Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD). Charles D. Fraser, Jr., MD, chief of pediatric and congenital heart surgery at Texas Children’s and professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will serve as the National Principal Investigator for the Investigational Device Exemption prospective study. As NPI, Fraser will work in cooperation with 10 U. S. hospitals and two Canadian hospitals, in collecting and reporting data to the United States Food and Drug...
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