The Food and Drug Administration said 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.
Photo: COURTESY OF medscape.com
FDA APPROVED: (R-L) Adult and pediatric Berlin Heart Excor ventricular assist devices.