The FDA has given the green light to a tiny device made by Abbott that can fix a common heart defect in newborns, especially premature babies.
The new device is tiny, even smaller than a pea.
It can be used in babies weighing as little as two pounds and it could help up to 12,000 infants every year.
Irie Felkner is an active toddler today, but born at just 27 weeks, she and her twin brother struggled to stay alive.
Irie had a congenital heart defect called PDA, a potentially life-threatening opening between 2 blood vessels leading from the heart.
That opening normally closes shortly after birth, but because Irie was born so early, it did not close.
Doctors inserted this tiny device, the Amplatzer Piccolo occluder, through a catheter, to seal the opening.
In the past, babies were kept on ventilators until they were big enough for more invasive surgery.
And some babies can't survive that long.
"If it wasn't for this device, we might still be in the hospital today," said Irie's mother, Crissa Felkner.
"It was a miracle to us," said Irie's father, Matt Felkner. "She was not able to breathe on her own. We watched her just struggle, watching your daughter's lungs, her chest collapse like we did. And three days later after the procedure to have the device, she was able to breathe on her own."
Irie is still small, but healthy and keeping up with her twin.
An adult version of the Amplatzer device has been in use for nearly 20 years.
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FDA approves new heart device for premature babies
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