(RxWiki News) U.S. Food and Drug Administration officials have given the green light to a device designed to support weakened hearts in children with heart failure who are awaiting a transplant.
The mechanical pulsatile cardiac assist device, called the EXCOR Pediatric System made by a German company Berlin Heart, helps keep pediatric patients alive while they are waiting to receive a donor heart. It comes in graduated sizes designed to fit kids from infants to teenagers.
"Consider becoming an organ donor."
Dr. Susan Cummins, chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health, called approval of the device a step forward, noting that it is the first such device approved for children. She said that similar devices for adults are too large for use in critically ill children to keep them alive while they wait for a new heart.
The device is made of one or two air-driven blood pumps, numerous tubes that connect the blood pumps to heart chambers and the great arteries, and the driving unit.
During the main U.S. study, 48 children were found to have better survival to transplant as compared to extracorporeal membrane oxygenation (ECMO), the current standard of care. ECMO is not approved by the FDA. As part of the research, investigators found that stroke is a risk of using EXCOR.
Pediatric heart failure is far less common than in adults. Heart transplants can relieve the symptoms in children, but far fewer donor hearts are available for them, which can lengthen the waiting period. FDA officials report that the average wait time for a donor heart in an infant is 119 days. Up to 17 percent of children and 23 percent of infants die while awaiting a heart transplant.
EXCOR was approved under a Humanitarian Advice Exemption, designed for approving devices that affect fewer than 4,000 U.S. patients a year. Much like traditional applications for approval, the company had to prove safety of the device, but instead of having to show a reasonable assurance of effectiveness, EXCOR needed to prove it would offer a probable benefit that would outweigh the probable risk of injury or illness.
