| FDA approves first heart pump for kids |
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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. (Source: AP) Subscribe to our RSS feed to stay in touch and receive all of TT updates right in your feed reader |



















