FDA Approves Pediatric Cardiac Assist Device

A cardiac assist device, called the EXCOR Pediatric System, for children with severe heart failure as been approved by the U.S. Food and Drug Administration (FDA). The pulstile mechanical circulatory support device can keep children alive until a suitable donor heart can be found, according to the company—Berlin Heart, a German firm.

The EXCOR Pediatric System comes in various sizes that can fit newborns to adolescents.
“This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children,” said Susan Cummins, M.D., M.P.H, 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.”

The system consists of up to two external air-driven (pneumatic) blood pumps, a series of tubes that connect the pumps to heart chambers and arteries, and a driving unit.

Heart transplantation is an effective treatment for children with severe heart failure. Even though heart failure is much rarer among children than adults, finding donor hearts for kids of the right size is not easy. Pediatric patients often have to wait much longer than their adult counterparts for a suitable organ. An infant, for example, typically has to wait about 119 days. In the United States, 12-17 percent of children and 23 percent of infants with heart failure who are waiting for a donor heart die before a suitable one is found, according to the FDA.

A U.S. study involving 48 patients found that the EXCOR system improved children’s chances of surviving to transplant, compared to the use of extracorporeal membrane oxygenation, which is the current standard care.

The EXCOR Pediatric System carries a risk of stroke and serious brain damage that may come with it. However, FDA reviewers decided that the benefits of this device outweigh the risks.

The FDA Office of Orphan Products Development designated the EXCOR as an Humanitarian Use Device (HUD). HUD is a medical device designation aimed at helping in the diagnosis or treatment of diseases or conditions that affect fewer than 4,000 patients each year nationally.

The EXCOR was approved under a Humanitarian Device Exemption.