FDA Logo Doctors usually find it difficult to catch hold of a heart donor for children suffering from heart failure. But, can patients with heart failure survive till a donor is available? Striving to help kids with an impaired heart survive till the heart transplant procedure is conducted, the team from the US Food and Drug Administration (FDA) has approved of a medical device which aids the functioning of the dysfunctional heart.

This device namely the EXCOR Pediatric System is a mechanical pulsatile cardiac assist instrument manufactured at Berlin Heart in Germany. It is customized to fit children of all age-groups from newborns to teens.

Susan Cummins, M.D., M.P.H, chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health, commented, “This is a step forward, it 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.”

The device comprises 1 or 2 blood pumps powered by air at the exterior along with many tubes that hook the pump to the heart chambers, the arteries and the driving unit. In the study conducted, about 48 patients were exposed to this device.

The results showed that the device apparently improved their condition as compared to the standard mode of treatment in the form of extracorporeal membrane oxygenation (ECMO). The latter is not FDA approved though.

The EXCOR Pediatric System is already approved by the Humanitarian Device Exemption (HDE) team. Now, that the FDA has given its approval, applicants are allowed to promote the device by conforming to certain restrictions.