SEATTLE, Wash. (WPVI) -- The Food and Drug Administration has approved the world's smallest mechanical heart valve - the only one intended for newborns.
And Sadie Rutenberg is proof of its success
Sadie was born with a heart defect affecting the valves.
After 2 open-heart operations, her heart still didn't work well, and she was too weak for a transplant.
Dr. Jonathan Chen at Seattle Children's hospital offered Sadie's parents the chance to be in an FDA trial of a tiny 15-millimeter valve made by Abbott.
It is the first designed for pediatric patients in need of valve replacements who may have no other approved options.
"We replaced the valve and she was off the races. She turned into a different child. She was able to eat and grow," says Dr. Chen.
3 years later, Sadie is full of energy.
"Looking at her, you'd have no idea she's been thru 5 heart surgeries," according to Lee'or Rutenberg, Sadie's dad.
"Having an opportunity to try this valve was huge and so exciting," he added.
Dr. Chen said he was grateful to the Rutenbergs for their willingness to try the experimental device.
"Without the Sadies of the world, we wouldn't have these valves on the shelf," he said, adding that they will help countless other children with valve defects.
Though Sadie will need new valves as she grows, her parents say without the first valve, she wouldn't be here
You can read more about the new valve at: World's Smallest Heart Valve.