FDA Approves New Cardiac Device That Can Treat Smaller Babies | WBNS-10TV Columbus, Ohio

Every year, nearly 12,000 babies of very low birth weight are born with a common heart defect that requires immediate attention.

Now the FDA has approved a new device that can treat the smallest babies.

Twins Irie and Judah Felkner of Columbus were 12 weeks ahead.

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Irie, born at just 1 pound 13 ounces, had a heart defect known as the patent ductus arteriosus (PDA).

"Honestly, I was really scared that we were not going to take her home," said their mother, Crissa Felkner.

A PDA is a potentially lethal opening between two blood vessels that go from the heart, which increases blood flow to the lungs and makes breathing difficult.

The doctors informed the Felkners of a new closing device called Piccolo. Smaller than a pea, the Abbott device can be implanted in babies weighing as little as two pounds by a minimally invasive procedure using a catheter to direct the device to the heart.

Dr. Evan Zahn from Cedars Sinai Smidt Heart Institute explains how it works.

"The Piccolo device is advanced in the PDA simply by pushing it gently. So there is the first record, there is the middle section and there is the last record, "said Dr. Zahn. "It goes straight into the PDA and the branch almost immediately, we can reposition it by simply pulling it into the catheter and remaking it all up until we think it's perfect."

Since it is minimally invasive, Dr. Zahn explains that many babies can be weaned more quickly from a ventilator.

Irie was one of the first babies in the United States to have this device during tests. She was breathing alone three days later.

"It's part of the history of medicine," Criss said.

Now, Irie and Judah, both 18 months old, have no limit and their mother could not be more grateful.

PDAs account for up to 10% of all congenital heart defects.

For most babies, the PDA closes just after birth, but for premature babies, it tends to stay open.

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