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FDA Advisory Panel Unanimously Recommends Approval of EXCOR(R) Pediatric Ventricular Assist Device for Use in the United States
Date:7/26/2011

BERLIN and THE WOODLANDS, Texas, July 26, 2011 /PRNewswire/ --

 

At the request of Dr. Bram Zuckerman, Director, Division of Cardiovascular Devices, Center for Devices and Radiologic Health of the United States Food and Drug Administration, a special panel was convened on Thursday July 21 in Gaithersburg, Maryland to review the results of the EXCOR® IDE clinical trial.  The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the EXCOR® VAD as it pertains to an application for Humanitarian Device Exemption (HDE) approval. This 22 member panel was comprised of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics, and other areas of expertise.  It also included patient, consumer, and industry representatives. The panel was chaired by Dr. Clyde Yancy, Chief of the Division of Cardiology at Northwestern University School of Medicine in Chicago, Illinois.  

In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled.  Working together over several months, including several face to face meetings, this group, now affectionately termed the Berlin Heart "Dream Team", worked very hard to be well prepared. The main presentation and the bulk of the clinical data and trail results was presented to the Panel by the National Principal Investigator of the study, Charles D. Fraser, Jr., M.D., FACS, Surgeon-in-Chief, Clayton Chair in Surgery, Donovan Chair and Chief, Congenital Heart Surgery, Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine and Charles E. Canter, M.D. Medical Director, Heart Failure/Transplant Program / St. Louis Children's Hospital, and Professor of Pediatrics, Washington University School of Medicine. &#
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