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A pea-sized device used to seal tiny but potentially deadly holes in the hearts of premature infants has been approved by U.S. regulators, making it one of the smallest complex medical devices ever invented and cleared for sale.
Abbott Laboratories’ Amplatzer Piccolo Occluder is one of the first treatments to become available for a common congenital defect that can become dangerous for premature infants. The device can be used in babies weighing as little as two pounds in cases where a hole in the heart used to deliver oxygen-rich blood in the womb doesn’t close after birth.
The Piccolo is threaded into the heart using a catheter that runs through the femoral vein in the thigh. That avoids a taxing surgery for the undersized patients, who are often on ventilators, said Evan Zahn, director of the congenital heart program at Cedars-Sinai Smidt Heart Institute in Los Angeles.
“We’ve never had anything like this, a device from a major medical manufacturer that was specifically designed with these tiny, really at risk, very fragile babies in mind,” said Zahn, the lead investigator of the study that led to the device’s approval by the U.S. Food and Drug Administration Monday. “We’re talking about babies the size of the typical water bottle we all drink out of. They are incredibly frail, fragile and at risk for terrible morbidity and mortality.”
The Piccolo is not expected to be a major sales driver for the Abbott Park, Illinois-based company. Instead, it represents a significant technological advance as medical-device manufacturers work to make their products ever smaller and easier to place in the body without taxing surgeries.
Everyone is born with a small hole in their heart, a condition called patent ductus arteriosus. In the womb, the hole allows a fetus’s blood to bypass the lungs and get oxygenated blood directly from the mother.
Usually, the hole closes a few days after delivery. In some premature newborns, however, it never does, making breathing difficult and leading to a host of potential complications. They include developmental delays, damage to the brain and bowel because they aren’t receiving the blood they need and injuries to the lungs that are flooded with fluid.
For years doctors performed open-heart surgery to close the hole, a procedure now thought to do more harm than good to the smallest patients, Zahn said. Other treatments include medicine to ease the symptoms and encourage closure, though in most cases doctors, patients and families simply wait and hope the hole eventually seals.
“We know it’s there and we know it’s bad, but we have to bite the bullet and hope the kids pull through,” Zahn said of existing medical practice.
The company hasn’t yet announced a price for the Piccolo.
Medical Trial
Each year about 60,000 infants are born prematurely in the U.S., including nearly 12,000 with holes large enough that they cause symptoms.
Several hundred young patients have already received the device in trials that led to the approval. Irie Felkner was born 13 weeks early on Aug. 3, 2017 with the condition. Her twin brother Judah, who was born first and weighed more, didn’t have the same problem. Irie’s doctors and parents waited several weeks in hopes the hole would close on its own, and tried unsuccessfully nine times to take her off a ventilator.
Imaging studies showed the hole was getting bigger and at six weeks of age and weighing just under two pounds, Irie received the Piccolo. Three days later, she was breathing on her own.
“My daughter has improved to the point where she has no limitations,” said Irie’s mother Crissa Felkner, a 37-year old title agent from Lancaster, Ohio. “She’s just a normal toddler. Her favorite things right now are being held upside down by her feet and doing back bends. She likes to try to read and play with anything her brother has.”
Irie was part of a 50-patient study conducted at eight centers across the U.S. to win FDA approval of the device. Another 150 children participated in a continued access program that provided more safety information about the Piccolo.
Abbott plans to expand availability of the device to other medical centers once they have received the necessary training, said Rick Olson, divisional vice president of product development at the company’s structural heart business.