New Device Approved for Children With Heart Failure
FRIDAY, Dec. 16 -- A cardiac assist device that's designed to keep a child with heart failure alive until doctors can find a donor heart has been approved by the U.S. Food and Drug Administration.
The blood-pumping Excor Pediatric System is produced in different sizes to fit newborns to teens. While heart failure is rarer in children than adults, there are also fewer pediatric-size heart donors, the FDA said in a news release.
These and other factors make the average waiting time for an infant-sized heart 119 days, the FDA said, so as many as 23 percent of infants die while waiting for a heart transplant. As many as 17 percent of children die under the same circumstances.
Excor has been designated a humanitarian use device by the FDA, since it affects fewer than 4,000 people in the United States each year. The makers of such devices must show that their use outweighs the devices' risk of illness or injury, the agency said.
The Excor system is produced by the German firm Berlin Heart.
Medline Plus has more about heart failure.
Posted: December 2011