World’s First and Only Device Now Approved Specifically for Premature Babies with PDA, a Life-Threatening Heart Defect
Most parents-to-be anxiously await the birth of their child. But those parents never wish for things to happen too early. Unfortunately, approximately 60,000 premature babies in the U.S. are born early each year, with very low birth weights. Parents of these children never imagined that they’d be watching their baby fighting for their life in the neonatal intensive care unit. One common complication for preemies is heart-wrenching news for parents: Their baby could have a life-threatening opening in the heart called patent ductus arteriosus (PDA) that often requires urgent treatment to survive.
Since February is American Heart Month, Anthony Daly, whose baby Tony was born prematurely with PDA, joined EverydayFamily’s Shiloh Johnson, along with Dr. Evan Zahn, who implanted the world’s first and only device approved specifically for premature babies – smaller than a pea– in baby Tony’s heart. See the full interview here:
Dr. Zahn explained more about PDA. It’s a blood vessel that every baby is born with and it’s genetically programmed to close in the first few days of life. However, for premature babies, this system just isn’t intact yet, and for nearly 12,000 (one out of five) premature babies this PDA stays open. This results in too much blood being stolen away to the lungs. This blood was supposed to go to other organs, like the brain, and this can result in organ damage. PDA is not typically thought of as a fatal condition, but it can be a contributing factor to the loss of a premature baby.
PDA is typically diagnosed in the NICU. Usually, if there is a heart murmur present in a premature baby, an ultrasound will be ordered, and this is easy to spot on an ultrasound or an echocardiogram.
Before this new device, doctors would try intravenous medications to close the PDA, which worked about 50% of the time (although with premature babies, it is less likely to work in the first place). If the medicine didn’t work, the other choices were heart surgery on the premature infant to close the PDA … or accepting that it was a condition the baby would have to live with.
Recently approved by the FDA, the Abbott Piccolo device is the world’s first medical device that can be implanted in the tiniest babies weighing as little as two pounds using a minimally invasive procedure to treat this common heart defect. Parents of pediatric patients who urgently need corrective treatment for their PDA now have hope for premature babies who are not responsive to medical treatment and/or ineligible for open-heart surgery.
Dr. Zahn said it’s a historic approval by the FDA. The Abbott Piccolo device is a tiny, wire-mesh device made of memory metal. Once it is inserted into the PDA, it expands and takes the shape of the opening, plugging it off. This means no surgery, no stitches. Just a Band-Aid of sorts on the insertion site! It’s so much safer and less traumatic for premature babies who are already so fragile.
Next, Daly shared his son’s story. Baby Tony was born prematurely at 26 weeks and 6 days, weighing 2 lbs. and 3 oz. “We knew it was coming, my wife had been in the hospital since 23 weeks,” explained Daly. “We were well prepped on what to expect.” Within days, the PDA was deemed open, and it started to affect Baby Tony’s intestines after a few weeks. This is a dangerous side effect called NEC (Necrotizing enterocolitis), which very few babies survive. Dr. Zahn met with Daly and his wife and explained the Abbott Piccolo device. Daly and his wife were ready to try it and, as Daly says, Dr. Zahn solved the problem.
These days, Baby Tony is doing great. He is 3.5 years old, running around like a wild gazelle, and wearing his parents out. All in all, a totally normal three-year-old! The family keeps in touch with Dr. Zahn as a friend now, not for follow-ups.
Dr. Zahn explained that this is one of the things that makes this device so remarkable. “This is a one and done procedure.” After the Abbott Piccolo device is inserted, the PDA closes immediately. The doctors follow the baby while they’re still in the NICU to make sure they’re getting better. Once they’re discharged, the doctors check in on them at their six-month appointment. Then they’re done! The device never needs to be replaced or taken out. And the kids who have the device should lead a normal life, with no special care.
More and more hospitals are training to insert the Abbott Piccolo device across the country. To learn more, visit abbottpiccolo.com.