PHILADELPHIA — A first-in-the-world device is now allowing doctors to treat patients with congenital heart disease in a less invasive way.
That means less time in the hospital and an easier recovery.
It's great news for 51-year-old Russell Soloway who has been preparing his body for a second open-heart surgery that he knew he'd need someday.
Soloway was born with a congenital heart condition and had his first open-heart surgery as a child.
"One of the first at my age to have it repaired," Soloway said.
Three years ago, Soloway's cardiologist determined his pulmonary valve was leaking.
At the time, Soloway was a busy federal litigator and hated the idea of slowing down for a major procedure.
"Four to eight months of recovery and you know, this and that. And I'm thinking, wow, that would really disrupt my life," he said.
Instead, in October 2019, Soloway became one of the first patients in the world to undergo a procedure using the Harmony Transcatheter Pulmonary Heart Valve.
"The advantages to the technology are you get the same benefit of having open-heart surgery in that you have a functioning valve implanted, but it's done through a small incision in the leg, and you go home the next day," said interventional cardiologist Dr. Matthew Gillespie.
The valve is designed to stay firmly in place, without sutures.
For Soloway, recovery was relatively easy.
"By the third day, I was basically back to normal," he said.
And soon after the procedure, he was back on the trails, hardly missing a beat.
Soloway had the Harmony Transcatheter Pulmonary Valve inserted in 2019 as part of a clinical trial.
After the trial was completed, the FDA approved the Harmony valve in March 2021.
How effective is the Harmony valve?
The Harmony valve's primary effectiveness goal was the percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six months.
Among patients with evaluable echocardiography data, 89.2% of them achieved the primary effectiveness goal.
The Harmony TPV device was granted breakthrough device designation for the treatment of pediatric and adult patients with severe pulmonary valve regurgitation.
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