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FDA Approves EXCOR Pediatric System

Updated Dec. 19, 2011

The Food and Drug Administration on Dec. 19 approved the EXCOR Pediatric System, made by Berlin Heart, for use in pediatric cardiovascular patients. The device comes in graduated sizes to fit children from newborns to teens.

According to Susan Cummins, MD, MPH, chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health, the EXCOR Pediatric System is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children. “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," she said.

In the primary U.S. study group of 48 patients, the use of the device was found to improve survival to transplant in patients when compared with the use of extracorporeal membrane oxygenation (ECMO) which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR Pediatric System.

The EXCOR was designated as a Humanitarian Use Device (HUD) by the Office of Orphan Products Development at the FDA. It was approved under a Humanitarian Device Exemption (HDE). In July 2011, the ACC urged approval in formal comments to the FDA.