The FDA has approved the first cardiac assist device for children with heart failure awaiting a transplant.
The approval of the EXCOR Pediatric System comes six months after an FDA advisory panel unanimously agreed that the device was safe and that its benefits outweighed any risks.
The EXCOR from Berlin Heart is the only cardiac assist device that comes in sizes appropriate for children, from newborns to teens.
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.