FDA Approves Device To Treat Premature Babies Born With Common Heart Defect
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PHILADELPHIA (CBS) – Tiny babies are getting help from a big scientific innovation. The FDA has approved a new device that can treat the tiniest babies who are born with a common heart defect.
Scientists have been tracking the progress of one little girl who was one of the first in the country to receive the device.
Irie and Judah Felkner are typical toddlers now, but the twins have been through a lot.
Born 13 weeks early, they were fighting for their lives.
Then came the diagnosis that Irie, born weighing just one pound, 13 ounces, had a heart defect known as a patent ductus arteriosus or PDA.
"I was honestly, truly scared that we were not going to bring her home," said Crissa Felkner, Irie's mother.
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A PDA is a potentially life-threatening opening between two blood vessels leading from the heart, which increases blood flow to the lungs, making it hard to breathe.
Doctors told the Felkners about a new device to close the opening called the "Piccolo."
Smaller than a pea, the device from Abbott can be implanted in babies weighing as little as two pounds through a minimally invasive procedure using a catheter to direct the device to the heart.
"You put in this little plug, it takes 20 minutes," said Dr. Evan Zahn "The Piccolo device is advanced into the PDA just by gently pushing it out. So, there is the first disc, there is the middle section and there is the last disc. That goes right into the PDA and plugs it almost immediately, we can reposition it by just drawing it back in the catheter and doing the whole thing over again until we think it's perfect."
Irie was one of the first babies in the United States to have the device while it was being tested.
She was breathing on her own just three days later.
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"She is a part of medically history," said Felkner. "That's crazy at six weeks old, look at what you are doing for the world Irie."
Now, 18-month-old Irie and Judah have no limitations and their mother couldn't be more grateful.
Doctors say PDA accounts for up to 10 percent of all congenital heart disease, it usually repairs itself after birth but premature babies tend to need intervention.