The FDA has given its blessing to Berlin Heart's device to keep children with heart failure alive until a donor for transplant is found. The EXCOR pediatric ventricular assist device, which is approved for use in Europe and Canada, is now the only VAD designed specifically for the pediatric population to be approved in the U.S.
In the primary U.S. study group of 48 patients, use of the Berlin Heart device was found to improve survival to transplant in patients when compared with extracorporeal membrane oxygenation, which is the current standard of care, although not FDA approved. Stroke, which can cause serious brain deficits, is a risk of the EXCOR system.
"This is a step forward, it is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children," said Susan Cummins, chief pediatric medical officer in the FDA's Center for Devices and Radiological Health. "Previous adult heart assist devices were too large to be used in critically ill children to keep them alive while they wait to get a new heart."
Previously, EXCOR was only available to the few children's hospitals around the country that participated in its clinical trials, said Robert Stewart, chair of pediatric thoracic and cardiovascular surgery at the Cleveland Clinic's Children's Hospital. "There were individuals who could benefit but didn't get it because of the hurdles," said Stewart, as quoted by Bloomberg. "These are relatively small numbers compared to the thousands of adult cases in the United States, but it will mean a huge difference for those individuals."
Treating pediatric patients has proven difficult. Very few devices are developed or assessed specifically for use in patients younger than 21. However, in March 2010, the FDA made strides by announcing that it would begin requiring device manufacturers to provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure--even if it is only intended for adults.
- see the FDA's release
- check out Berlin Heart's release
- get more from Bloomberg
Berlin Heart pediatric offering could soon help U.S. patients
FDA sees promising Edwards valve as safe, effective
Med devices harm 70K kids annually
FDA to require pediatric information from devicemakers