The EXCOR Pediatric System, made by the German company Berlin Heart, can be sized to fit young people from newborns to teenagers.
"This is a step forward. It is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health.
"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 added in a statement Friday.
The device was tested on a group of 48 US patients, and was found to improve survival rates for transplant patients compared with the use of extracorporeal membrane oxygenation, the current standard of care, though not FDA approved.
As a whole, a reported 12-17 percent of children and 23 percent of infants die while they await heart transplants, according to the FDA.