FDA to Approve Berlin Heart for Child Transplant Patients

A blood-pumping device commonly referred to as the Berlin Heart, which bridges children to transplant while they're awaiting a heart, is facing imminent approval by the Food and Drug Administration (FDA). It's already approved in Canada and has been used Europe since 1990.




Currently, pediatric heart surgeons have to get special approval from the FDA on a case-by-case basis to use the device. The process, part of the FDA's compassionate use program, requires a bureaucratic undertaking involving letters of support from several other physicians. The process isn't onerous, but it takes up valuable time that many children don't have.   More Read