The Berlin Heart EXCOR(R) Pediatric VAD is a mechanical cardiac support system for critically ill pediatric patients suffering from severe heart failure. The system is designed to support pediatric patients of all age groups, from newborns to teenagers, and is intended to bridge patients awaiting heart transplantation from days up to several months, until a donor heart becomes available. The Berlin Heart EXCOR(R) Pediatric VAD, which has previously been approved for use in Europe and Canada, is now the only Ventricular Assist Device that is designed specifically for the pediatric population to be approved in the United States.
The National Principal Investigator for the Berlin Heart EXCOR(R) Pediatric VAD study, Charles D. Fraser, Jr., M.D., Surgeon-In-Chief and Head of the Division of Congenital Heart Surgery at Texas Children's Hospital and Professor of Surgery and Pediatrics, Baylor College of Medicine in Houston, Texas, said, "On behalf of the many investigators, coordinators, and administrative personnel involved in the study, I am extremely gratified by the news that the EXCOR(R) Pediatric VAD has achieved an HDE approval by the FDA. This is a landmark event for children suffering from terminal heart failure. The medical community is now able to offer this lifesaving device to support desperate children who would not otherwise survive while awaiting a heart transplant. This ushers in a new era for children with heart disease. The study involved an incredible effort from 15 centers across North American with extensive experience in pediatric heart failure and transplantation and should serve as a model for future collaborative device investigations involving children, industry, medicine, and the FDA."
Dr. Stefan Thamasett, Chairman of the Board of Berlin Heart, said, "This milestone marks the closure of a long process, and we are very happy that we were able to reach this for the Berlin Heart Group. Our special thanks goes to all of the participating clinics and their doctors as well as our countless patients and their relatives; and of course we would like to thank our employees, because without their tireless commitment we would not have been able to reach this goal. We are looking forward to a new and exciting chapter in the history of Berlin Heart."
It is intended for use by pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and who require circulatory support.
The advisory panel in July reviewed results from studies that involved two pediatric cohorts -- children ages 30 days to 4 years and children ages 4 to 16. In both cohorts, the EXCOR had better results in terms of survival to transplant compared with extracorporeal membrane oxygenation (ECMO). ECMO is the current standard of care, but it is not FDA approved.
The FDA has designated the EXCOR a Humanitarian Use Device because the condition for which it is approved affects fewer than 4,000 individuals in the U.S. annually.
"Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart," said Susan Cummins, MD, MPH, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health, in a statement.
The mechanical pulsatile device consists of one or two external pneumatic blood pumps, connecting tubes, and the driving unit.
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