Riley Applauds FDA Approval of Berlin Heart Device
A Riley Hospital for Children at IU Health Release
INDIANAPOLIS – The U.S. Food and Drug Administration (FDA) announced today that it has approved the Berlin Heart, Inc. EXCOR® Pediatric Ventricular Assist Device – a move that Riley Hospital for Children at Indiana University Health has been anxiously awaiting for years.
The Berlin Heart is a mechanical heart support system for pediatric patients suffering from severe heart failure. The device can take over full or partial function of a damaged heart, restoring normal blood flow. It is a last resort for pediatric patients with failing hearts and is used to allow time for the heart to heal or to buy time until heart transplantation.
“This is an important day for the health and well-being of children in the United States,” said Dr. Mark Turrentine, director of Pediatric Cardiothoracic Surgery at Riley at IU Health and a professor of Surgery at the Indiana University School of Medicine. “The approval of the Berlin Heart is the first step towards ensuring that pediatric heart care in this country no longer lags behind that of adults. Now, children in the U.S. have the same access to this lifesaving technology as others worldwide.”
While the device has been implanted extensively worldwide, it did not have FDA approval until now. Originally, this left North American hospitals like Riley at IU Health without access to the one mechanical heart support system designed for children. This prompted Riley at IU Health to ask the FDA for special permission to import and implant the Berlin Heart. Riley at IU Health later established a protocol for obtaining the Berlin Heart, shared that with other institutions and served as a catalyst for use of the device in North America.
“Riley got involved with the Berlin Heart in 2003 because we recognized the gap in care for children with failing hearts. With no alternative therapy available, we decided to bring in the device from Germany,” said Daniel F. Evans, Jr., president and chief executive officer, IU Health. “The FDA approval validates our commitment to doing what’s best for all of our patients and in this case, enabling children to lead healthy lives into adulthood.”
Riley at IU Health has a long history with the Berlin Heart device:
- Turrentine performed the second (in 2003) and third (in 2004) Berlin Heart implants in North America – both of which were the continent’s first toddler cases.
- Bailey Hunsberger of Indianapolis was born with aortic stenosis and received Riley at IU Health’s third Berlin Heart implant (in 2005) at age 12. The device performed so well in Hunsberger that it allowed her heart to heal to the point she no longer needed a transplant and the device was removed. Now a 19-year-old sophomore at Indiana University in Bloomington, Ind., Hunsberger is studying biology and is doing great.
- Hunsberger became a high profile advocate for the Berlin Heart after the award-winning film “Heart to Heart,” produced by Indianapolis Motor Speedway Productions, documented her medical journey before, during and after her implant. The film, hosted and narrated by actor Patrick Dempsey, highlighted the need for advanced care and technology for children.
- Riley at IU Health was one of the original institutions involved in a clinical investigational study group formed to begin the FDA device approval process. Turrentine represented Riley at IU Health and helped to author the first major Berlin Heart publication in the U.S. Dr. Elaine Cox, Pediatric Infectious Disease at Riley at IU Health and an associate professor of Clinical Pediatrics at the IU School of Medicine, helped craft the study protocols for the device.
- Hunsberger and Cox testified in front of the FDA panel, which in July 2011 recommended approval of the Berlin Heart. Hunsberger testified as a patient; Cox testified as an expert advisor evaluating infectious complications.
- Riley at IU Health has implanted nine Berlin Heart devices to date – all performed by Turrentine.
“It’s an incredible honor and responsibility to have parents share their children with us and trust us to do everything we can to help their kids,” said Dr. Jeff Sperring, president and chief executive officer, Riley at IU Health. “This is an exciting day for our entire Riley family and we are very proud of the work we’ve done on behalf of all children – both here at home and across the country.”
“This device can mean the difference between life or death for some of our patients with complex heart problems,” Cox said. “We knew there had to be a better way to take care of these kids and it’s rewarding to see this final piece come together after all this time.”
Riley at IU Health was the only Indiana hospital ranked in the top 25 national programs for Cardiology & Heart Surgery in U.S.News & World Report’s 2011-12 edition of Best Children’s Hospitals.
To interview Dr. Mark Turrentine, Dr. Elaine Cox, Dr. Jeff Sperring, Bailey Hunsberger and/or her family, please call Kit Werbe at 317.963.7692.
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About Riley Hospital for Children at Indiana University Health For more than 85 years, Riley at IU Health has been one of the nation’s leading children’s hospitals. Each year, Riley at IU Health provides compassionate care, support and comfort to 215,000 inpatients and outpatients from across Indiana, the nation and the world. Part of Indiana University Health, our unique partnership with the Indiana University School of Medicine gives our highly skilled physicians access to innovative treatments using the latest research and technology. Discover the strength at rileyhospital.org.