New Device Approved for Children With Heart
FRIDAY, Dec. 16 (HealthDay News) -- 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
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