The ventricular assist device is very like the one that was used for former Vice President Dick Cheney, but it has been significantly scaled down to fit into children and babies.
Traci Shaffer is the mother of a 9-year old son, Lane, who survived 16 months on an Ohio transplant waiting list because he got a Berlin Heart.
"Without that device I wouldn't have my son."
reports that at birth Lane had a defect in his body that caused his heart to swell and eventually fail. What he really needed was a transplant, but with none available quickly enough, a Berlin Heart device would work. But because it was still unapproved in the U.S., it was hard to get. Shaffer says,
"The doctors said, 'This is experimental, it's not FDA-approved, and here's the thing: You might not even get it in time."
Lane's doctors wound up asking the FDA for emergency access to the Berlin Heart under a provision called compassionate use. Once they got FDA approval, they would then be able to order the device from Germany, bringing the wait time up to seven days. Shaffer says when they started the application process her son had only been given 7 to 10 days to live.
"The child has to be on death's door before you can even apply for it. We've seen kids that couldn't wait seven days. It's very scary."
Lane's weight was down to just 35 pounds when his Berlin Heart arrived at the Cleveland Clinic in May 2010. His ribs could be seen through his pale skin as he lay curled up in bed. But following a nine-hour procedure to implant the device, Lane began to improve. Shaffer was ecstatic
"Immediately after the surgery I could see the color of his skin had changed. His feet were no longer white and cold; they were pink and warm. His cheeks were rosy. That was the moment when you say, 'This is working.'"
The FDA's decision to approve the Berlin Heart means hospitals can stock the device in a range of sizes, from walnut-size pumps for babies to fist-size pumps for teens. The State Column
reports that the FDA decision was announced on Friday. The announcement said that the device would support children with weakened hearts or with heart failure and it would allow them to remain alive until a donor for a heart transplant could be found. The Berlin Heart pumps blood throughout the body when a child’s own heart has trouble doing it on its own.
Dr. Gerald Boyle is a pediatric cardiologist at Cleveland Clinic,
"I will sleep better knowing there's a Berlin Heart sitting here in the Cleveland Clinic. In the middle of the night, if we have a device here we can support the patient immediately."
But doctors agree that the Berlin Heart is really just a temporary fix, and that kids who receive it ultimately require a heart transplant.
Lane used the Berlin Heart until December 2010, when his parents got the call that his new heart had been donated. Now, his weight is up to 75 pounds, he plays sports, loves motorcycles and is eating regularly. But his journey is only half over. He will have to take anti-rejection drugs for the rest of his life, and he still may eventually require another transplant.