The EXCOR Pediatric System comes in various sizes that fit kids from newborns to adolescents.
Susan Cummins, M.D., M.P.H, chief pediatric medical officer in the FDA’s Center for Devices and Radiological Health, said:
“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.”
EXCOR Pediatric System helps keeps children with severe heart failure alive until a suitable heart is found
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 USA, between 12% and 17% of children and 23% of infants with heart failure who are waiting for a donor heart die before a suitable one is found, the FDA informs.
A US study involving 48 patients found that the EXCOR Pediatric System improved children’s chances of surviving to transplant, compared to the use of ECMO (extracorporeal membrane oxygenation); the current standard care.
The EXCOR Pediatric System carries a risk of stroke and the serious brain damage that may come with it. However, the FDA decided that the benefits of this device outweigh the risks.
The FDA Office of Orphan Products Development designated the EXCOR as an HUD (Humanitarian Use Device). 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 an HDE (Humanitarian Device Exemption); what the FDA describes as “similar to a premarket approval application in that the level of safety required for approval is the same.”
In order to get FDA approval, a medical device submitted through an HDE route needs to demonstrate that there is a “probable” benefit which is greater than the likely risk of injury or illness from its use.
Berlin Heart EXCOR Pediatric Implantation Video.mpg
Written by Christian Nordqvist