FDA Approves World’s Smallest Mechanical Heart Valve


Three years ago, Lee’or Rutenberg and his wife knew their baby girl Sadie would be born with heart problems. Within months, young Sadie became the first patient to receive a pediatric heart valve as part of the HALO clinical trial, which enrolled pediatric patients five years of age or younger with a diseased, damaged, or malfunctioning heart valve across the U.S.

The FDA recently approved the Abbott 15mm rotatable mechanical heart valve, the world’s smallest and only mechanical heart valve designed for newborns and infants in need of a mitral or aortic valve replacement. This new valve now offers hope for those pediatric patients in urgent need of a valve replacement who may have no other approved options.

heart valve
Image via Pixabay

Sadie’s father Lee’or, along with the doctor who performed Sadie’s surgery, Dr. Jonathan Chen, joined EverydayFamily’s Shiloh Johnson to talk about the FDA approval of this new mechanical heart valve and how little Sadie is doing today. See the full interview here:

Dr. Chen explained that this valve has actually been available for several years, but only on protocol, which meant that to get one for a patient would take several days or even weeks.

But this new FDA approval means that the valve is now on the shelf. This means that doctors have instant access to it for patients who need it. This has a big impact on emergency operations. But it also has a huge impact on infants and children since every minute counts with young children and congenital heart disease.

The prognosis for infants and children who need a new valve is significantly better because of this 15mm rotatable mechanical heart valve. Before, a child in need of a new valve would have to wait in the ICU for weeks or even months to grow enough to accept an adult-sized prosthesis.

So, what are the qualifications for this valve?

Dr. Chen told us that every infant or child who needs a heart valve should be a candidate for this. However, they have to have a valve size that is a diameter of 15mm, so that the valve fits correctly. 

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Next, Lee’or told us more about Sadie’s story.

Even though they knew Sadie would be born with heart problems, Lee'or and his wife didn't know the extent of the issues until they brought her home. “When Sadie came home from the hospital she was eating all the time but not putting on weight. Her skin didn’t look great. She was working too hard and we knew something was really wrong around 2 months old,” Lee’or said.

They had to spend a decent amount of time in the ICU to allow Sadie to grow enough to accept the smallest valve available. But as soon as she got this valve, she turned around. Sadie got her energy back and she’s now three years old and unstoppable. She’s a firecracker who loves the zoo and climbing on everything (the climbing gives her mom and dad a bit of a heart attack!) Because of this heart valve, Sadie is happy and growing and doing so well. She and Dr. Chen even came up with a cute way to describe the valve replacement: They say she put a “sparkle” in her heart! How cute is that?!

So, where can you go for more information about these heart valves? Learn more by visiting Mended Little Hearts at https://mendedhearts.org/, abbott.com, or family resource chat rooms and support groups for congenital heart disease found via hospitals. 

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Here's hoping this information helps you or someone you know put a “sparkle” in a child's heart.

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FDA Approves World’s Smallest Mechanical Heart Valve

I've lived all over the place! I was born in Hawaii, grew up in the Canadian Rocky Mountains, enjoyed some time in the cities of the Bay Area, and even spent a few years in Arizona. These days I am living in beautiful Colorado and loving it. I live with my husband, baby boy, my mom, and our 5 pets (3 cats, 2 dogs). There's a lot of love in our little condo! A few of my favorite things include: Pretty dresses (especially ones I can wear while breastfeeding/pumping these days.) Tea parties wi ... More

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