FDA approves Berlin Heart for children

December 16, 2011

Young patients with heart failure seeking treatment at Children's Medical Center ( www.childrens.com ) will not have to wait as long to receive a mechanical device designed to keep their hearts beating since the technology was officially approved Friday by the U.S. Food and Drug Administration.

The mechanical cardiac assist device, commonly called a Berlin Heart, received FDA approval to be marketed under certain use restrictions. Up until now, the tool had been treated as an experimental device.

Known as Compassionate Care Use, artificial Berlin Hearts provide mechanical circulatory support, extending the life of heart patients for up to one year until an appropriate heart match is found. Since 2000, pediatric heart surgeons across the U.S. have had to appeal to the FDA for approval on a case-by-case basis under Emergency Use regulations because the Berlin Hearts were only approved for adult patients.

The FDA's approval Friday will greatly benefit children with heart failure who need the tool to survive while they wait for heart transplants, one Children's Medical Center physician said.

"For the ones who need it, it's tremendous," said Dr. William Scott, co-director of the Heart Center and director of the cardiology division at Children's Medical Center. "Currently, the device is considered experimental. You can't get it quickly and have to go through an (Institutional Review Board) protocol – so it's been treated as if it was a research project.

"The fact that we don't have to do that now – that we can turn around and get it as we would any other medical device — is tremendous," said Scott, who is also a professor of pediatrics at the University of Texas Southwestern Medical Center and director of that institution's cardiology division. "The ability to get it here will dramatically shorten the amount of time you wait."

The Berlin Heart consists of one or two external air-driven blood pumps, multiple tubes to connect the pumps to the heart and a driving unit. There is no other device that will work on a young patient experiencing heart failure and needing a heart transplant, Scott said.

"I don't think we will necessarily use it more," Scott said of the device now that the FDA's approval has been granted. "We've used it every time we needed to. It's just that we will be able to get it more quickly now."

Children's Medical Center lauds the FDA for its approval of the devices. Children's is one of the leading pediatric hospitals in the nation for heart transplants, and in the past year has had as many as five patients on the device at one time.

The device saved the life of Rylynn Riojas, a 2-year-old Children's Medical Center patient who was in dire condition while waiting for a new heart. She received a Berlin Heart several months ago that will keep her alive while she waits for a heart transplant. Rylynn's struggle was featured in the Children's Medical Center TV documentary Children's Med Dallas.

About Children's Medical Center
Children's is a private, not-for-profit system. It's the fifth-largest pediatric healthcare provider in the country, with 559 licensed beds, two full-service campuses and 10 outpatient sites. It was the state's first pediatric hospital to achieve Level 1 Trauma status and is the only pediatric teaching facility in North Texas, affiliated with UT Southwestern Medical Center. For more information about Children's, please visit www.childrens.com.