It's widely used in Europe, but a medical device that saves the lives of children is hard to come by in this country.
It's called a Berlin Heart and recently it's credited with saving the life of a two-year-old girl.
Before her second birthday, Serafina Akard got very sick. She was sleeping more and eating less. Then, she had trouble breathing.
Her cardiologist admitted her to ICU, Serafina's mom, Suzann Akard said. And it was that night that she went into cardiac arrest.
Serafina needed a transplant. Finding a heart could take months, time Serafina did not have.
Cardiologist Stephen Roth said, "She had just days or at most a couple of weeks."
Doctors said only a Berlin Heart could keep Serafina alive until she could get a transplant. It's a mechanical heart that helps weak hearts pump blood. The only catch is that it is not FDA approved in the U.S.
"There is a pretty complicated process that we go through to get permission from the FDA,” Roth said.
The wait was agonizing, but Serafina's family never gave up.
Doctors pushed through the mass of red tape and got the device in record time.
When we caught up with Serafina, the Berlin Heart was attached to her chest.
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