Putting a 'sparkle' in Sadie's heart: World's smallest mechanical heart valve saves Seattle girl's life

SEATTLE -- Imagine you are a new mom spending maternity leave at Seattle Children’s and not knowing whether your baby is going to survive the night.

That is the story of the Rutenberg family. Their baby’s heart was failing.

The Seattle family says a tiny device, a first of its kind, saved their baby’s life.

“You don’t know how great you have it when you have a healthy child,” Lee'or Rutenberg said.

Lee'or is moved to tears when he thinks about the first year of his daughter’s life.

Her heart was failing at 2 months.

Sadie was hooked up to a breathing machine and heavily medicated due to the pain.

“When you look at your child and they are crying and uncomfortable and all you want to do is pick them up and put them on your chest and just pat their back and tell them it’s going to be OK, it’s tough,” Lee'or said.

Surgeries to repair a valve problem didn’t work and she was too weak for a heart transplant.

“There was so many days we didn’t know if she would make it through that day, I cried every day hoping that something would happen,” Wendy Rutenberg said.

Months of crying; then one day Dr. Jonathan Chen at Seattle Children’s would pose an idea that ultimately save Sadie’s life.

“We didn’t have another choice -- it was this or planning for her death,” Wendy said.

Chen told the Rutenbergs about a mechanical heart valve not yet FDA-approved. But Sadie could be the very first in a trial to prove its effectiveness to the FDA.

“Having this valve is revolutionary, it opens up the opportunity to operate much sooner,” Chen said.

It’s the world’s smallest mechanical heart valve designated just for infants and newborns. The device is 15mm, the size similar to a dime.

Chen applauds Abbott Laboratories for making a device the company can’t even profit from.

“The only reason why they developed this and investigated this is because of the kindness of their heart, which is kind of remarkable,” Chen said.

The need for a pediatric valve like this is low, compared to ones needed for adults.

Chen says only about 200 surgeries per year would need a pediatric valve nationwide.

But for those families who desperately need it, it’s life or death.

Due to the trial Sadie participated in years back, the pediatric heart device was approved by the FDA just three weeks ago.

That means the device will be on the shelves at hospitals, ready to be used more quickly without any hurdles.

When you ask Sadie about the heart surgery. she says Dr. Chen put a sparkle in her heart.