WASHINGTON — Federal health regulators have approved the first heart pump for children with heart failure, offering an important treatment option for patients who are too small to receive adult implants.
The Food and Drug Administration said Friday the device from Germany-based Berlin Heart will be used to keep children alive until they can receive a heart transplant. Very few medical devices are designed specifically for children, posing major challenges to doctors and surgeons who treat pediatric cases of life-threatening diseases.
Heart failure is rare in children, and the device was approved under a special program for diseases that affect fewer than 4,000 patients per year. Among infants, the typical wait time for a heart transplant is more than four months. Nearly a quarter of all infants die while waiting for a transplant, according to the FDA. And up to 17 percent of all children die while on the wait list for a transplant.
The Excor Pediatric System heart device comes in various sizes to accommodate patients ranging from infants to teenagers.
The device was studied in a trial of 48 patients, which showed that those implanted with the Excor device survived longer than those using a device similar to a heart-lung machine. The trial was supported by three FDA grants totaling $1.2 million.