FDA approves heart valve for babies after trial that started in Seattle

3-15-18 Sadie Rutenberg (KOMO photo).jpg

SEATTLE - The Food and Drug Administration has approved the first mechanical heart valve designed for infants and babies after a medical trial that started at Seattle Children’s Hospital.

The Masters 15-mm valve, made by Abbott, is the smallest of its kind in the world. It can be used to treat babies who are born with congenital heart defects.

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Sadie Rutenberg was the first child in the trial to receive the valve when she underwent surgery at Seattle Children’s Hospital in May 2015. She was 9 months old.

Sadie, now 3, was born with a complete atrioventricular canal defect. Simply put, she was missing the wall between the left and right sides of her heart. She underwent two open heart surgeries in her first few months of life, spurring talks of a transplant.

“All expectations were, if we didn’t do something quickly, she was going to die,” Sadie’s father, Lee’Or Rutenberg, said.

Then Dr. Jonathan Chen, the chief of congenital cardiac surgery at Seattle Children’s, approached the family with the opportunity to take part in the medical trial.

“Having an opportunity to try this valve was huge and so exciting, because it was a chance for us,” Sadie’s mother, Wendy Rutenberg, said. “Whether it worked or didn’t work, we wanted to try it.”

Now 3 and 1/2 years old, Sadie is full of life.

She still needs blood thinners, and she’ll need new valves as she grows up. She’s already outgrown one. But her parents insist the tiny innovation saved her life. And soon it may save many more.

With the FDA’s approval, hospitals can now stock up on the 15-mm valves for quick use when a child is in need. While children could receive the valve before, Chen says they had to receive special approval, which could take days.

“Postponing an operation by several days to simply wait for the paperwork and to get the valve available can be very risky,” Chen said. “Especially in these kids because these are the kids who are sometimes the most tenuous in the ICU.”

And Chen believes the new valve will offer surgeons a safety net for procedures aimed at fixing valves.

“That affords a whole different level of capability for us to both replace valves and also to entertain doing high-risk valve repairs,” he explained. “Because there’s some operations that we wouldn’t even entertain doing if we didn’t have a backup.”

More than 35,000 babies are born with congenital heart defects every year in the United States, according to the FDA.

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