LOS ANGELES — He’s happy, playful and full of life, but Jake Schumacher had a rough start in this world. He was born with four congenital heart defects, including narrowed arteries and a narrowed pulmonary valve.
What You Need To Know
- About 40,000 babies in the U.S. are born with congenital heart defects each year, according to the Centers for Disease Control and Prevention
- The experimental medical device called the Renata Minima Stent is being tested and studied in a clinical trial to grow with babies and toddlers
- Cedars Sinai Medical Center is one of four hospitals taking part in the device’s first clinical trial
- Dr. Zahn said the Renata Minima Stent, once FDA -approved, could be a game changer for children with this condition
About 40,000 babies in the U.S. are born with congenital heart defects each year, according to the Centers for Disease Control and Prevention. For first-time mom Yvette Honda-Schumacher, it was a difficult finding to process.
“I was definitely very scared. Definitely felt kind of alone because we didn’t know anybody in our family who had gone through anything like this,” she said.
At just five months old, Jake Schumacher had an open-heart surgery, then another surgery as a toddler to widen a narrowing with a metal mesh tube called a stent.
The device would eventually have to be replaced as he got older. But right before his third surgery, Yvette Honda-Schumacher and her husband were presented with an option that could eliminate the need for further open-heart surgeries.
The experimental medical device called the Renata Minima Stent is being tested and studied in a clinical trial to grow with babies and toddlers.
The catch? Jake Schumacher would be one of the first 10 children to try it.
“It was very scary, and it was kind of a leap of faith,” she said.
Dr. Evan Zahn is the Guerin Family Congenital Heart Program director at Cedars Sinai Medical Center.
The medical center is one of four hospitals taking part in the device’s first clinical trial and where Jake Schumacher had his surgery.
Dr. Zahn said the Renata Minima Stent, once FDA -approved, could be a game changer for children with this condition.
As the child grows, the stent can be expanded in increments to an adult size through minimally invasive surgeries. Using the device in the clinical trial has been going well so far, but there are some risks, Dr. Zahn said.
“Those are things like a rhythm disturbance that could be caused in the heart, even a tearing in a blood vessel in the heart. But, fortunately, to date we haven’t seen any of those,” Dr. Zahn said.
Jake Schumacher received his Renata Minima Stent placement in March of last year and went home the day after. As a mom, Yvette Honda-Schumacher was just happy to see him be a happy kid again.
“I’m hoping that he’s going to live a longer life,” she said. “This is going to help the longevity of his heart and that will give him a full life.”