Children's cardiac assist device approved by FDA

Medical News Today

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

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."
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