FDA approves device to treat heart defect in tiniest of babies

Irie and Judah Felkner may seem like typical toddlers now, but the twins have been through a lot in their young lives. Born 13 weeks early, they were fighting for their lives. Then came the diagnosis that Irie, who weighed just 1 pound 13 ounces at birth, 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,” the twins’ mom, Crissa Felkner, told CBS News.

A PDA is a potentially life-threatening opening between two blood vessels leading from the heart, which increases blood flow to the lungs and makes it hard to breathe. For most babies, the PDA closes on its own just after birth, but in premature babies it tends to stay open.

Each year nearly 12,000 very low birthweight babies are born with this common heart defect that needs immediate attention. PDA accounts for up to 10 percent of all congenital heart disease cases. 

Doctors told the Felkners about a new device recently approved by the FDA to close the opening. It’s called the Piccolo and it’s smaller than a pea. The device from Abbott can be implanted in babies weighing as little as 2 pounds through a minimally invasive procedure using a catheter to direct the device to the heart.

Irie Felkner was born with a heart defect.

Felkner family

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

“The Piccolo device is advanced into the PDA just by gently pushing it out. That goes right into the PDA and plugs it almost immediately,” he said. “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.”

Because the procedure is minimally invasive, Zahn says many babies can be weaned off a ventilator more quickly.

Irie was one of the first babies in the U.S. to get the device while it was still being tested. She was breathing on her own just three days later.

“She is a part of medical history. That’s crazy at 6 weeks old,” Felkner said.

Now 18 months old, both Irie and Judah have no limitations and their mother says she couldn’t be more grateful.

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