Heart-assist device for kids approved

Keeping critically ill children with weakened hearts alive until a donor heart can be found appears more hopeful with US Food and Drug Administration (FDA) approval of a cardiac-assist device specifically designed for children from newborns to adolescents.

The Excor Pediatric Ventricular Assist Device (Berlin Heart GmbH; Germany) is a pulsatile circulatory support device that consists of 1 or 2 external pneumatic blood pumps, tubes to connect the pumps to the heart chambers and great arteries, and a driving unit. It provides mechanical circulatory support for babies and children with terminal heart failure.

In a clinical trial, the device improved survival time to transplant in patients compared with the use of extracorporeal membrane oxygenation, which is the current standard of care. Stroke is a possible risk, however.

Children wait far longer than adults for a donated heart because fewer pediatric hearts are available for transplantation. A reported 12% to 17% of children and 23% of infants die while on the waiting list for a donor heart transplant.