The federal Food and Drug Administration has approved a mechanical device that could give children months of life while they wait for a donor heart.
The device called the Berlin Heart isn’t new, but the FDA approval means doctors can stock up and have the implant on hand for children who need it.
In the past, doctors at Nemours Alfred I. duPont Hospital for Children needed emergency clearance to use the device.
“In order to do so, we had to go through a lot of paperwork with the FDA to approve compassionate use. And the turn-around time on something like that could take up to 48 hours or longer–and sometimes impede the process of providing the best care to our patients,” said Marc Priest, coordinator of the heart-lung bypass program at A.I. duPont.
The device is implanted in the chest to support the pumping chambers of the heart. Tubes that come through skin are connected to an external pump.
Children can live with the implant for a year or more while their own heart heals or while waiting for a transplant.
“Sometimes they have congenital heart defects and end up in heart failure for which we don’t have a surgical correction, sometimes kids can develop a bad virus or cardiomyopathy that causes heart failure,” Priest said.
Different from other heart-support devices, the Berlin Heart is made in a range of sizes including very small versions for infants.