Sadie Rutenberg received the world's smallest mechanical heart value before her first birthday in 2015 and her progress helped win U.S. Food and Drug Administration approval for the device, KOMO-TV reported.
The 15-milimeter value, made by the medical technology company Abbott, is the smallest of its kind in the world, designed to treat infants with congenital heart defects.
Rutenberg was 9 months old when she received the device at Seattle Children's Hospital as part of a medical trial. She was born with a complete atrioventricular canal defect where she was missing the wall between the left and right sides of her heart, the television station wrote.
Doctors performed two open heart surgeries on the child in her first months to try to save her life, KOMO-TV reported. Dr. Jonathan Chen, the chief of congenital cardiac surgery at Seattle Children's, approached the family about the medical trial, per the television station.
"Having an opportunity to try this valve was huge and so exciting, because it was a chance for us," Sadie's mother, Wendy Rutenberg, told KOMO-TV. "Whether it worked or didn't work, we wanted to try it."
Sadie Rutenberg is now as lively as the typical 3-year-old, more than two years since getting the valve.
Last month, Abbott won FDA approval for what is called the Masters HP rotatable mechanical heart valve.
"There's an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive," Michael Dale, vice president of Abbott's structural heart business, said in a statement from the company.
"Abbott's new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart," Dale added.
KOMO-TV wrote that hospitals will be able to stock up on the tiny valves for quick use when a child is in need with FDA approval behind it. Chen said children would have needed special approval without the FDA nod.
"Postponing an operation by several days to simply wait for the paperwork and to get the valve available can be very risky," Chen told KOMO-TV. "Especially in these kids because these are the kids who are sometimes the most tenuous in the ICU."
Abbott wrote that congenital heart defects affect nearly 1 percent, or about 40,000 births each year. Children with badly functioning valves that cannot be repaired, a valve replacement procedure is now, Abbott said.
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