Innovative chronic pain surgery created in Minnesota close to FDA approval
A "first of its kind" surgery developed in Minnesota to provide relief from debilitating back pain is one step closer to FDA approval.
WCCO first learned about
SynerFuse in 2023
after a patient shared her chronic pain journey and the successful results a year after the surgery.
The path ahead looks promising for the innovative technology as researchers learn about more Minnesotans who took part in the initial trial.
Physical pain is part of the job for Jason Fleck.
"My muscles are sore at the end of the day," said Fleck, from Hillman, Minnesota.
In 2022, the construction tradesman hurt himself.
"I could hardly walk around. I was using a walker. I was using the walls to get to the bathroom from my bedroom. It'd take 10-15 minutes to get in and out of bed," said Fleck.
He found a clinical trial for
Synerfuse
, the world's first double infusion implant developed by specialists from the University of Minnesota and M Health Fairview.
The procedure combines traditional spine surgery with nerve stimulators.
"We remove tissue to take the pressure off the nerves, we place hardware to reconstruct and realign the spine and then we put direct nerve root stimulators onto these diseased nerves," said Dr. Rohan Lall, neurosurgeon at M Health Fairview.
That process alters the nerve's ability to send pain signals.
The nerve stimulators are controlled by the patient's phone.
"If I need to adjust the strength, I hit adjust strength and I pick which lead I want. L4, L5," explained Fleck.
Fleck's previous back surgeries required long recoveries and the use of opioids.
"I was on opioids for about two years dealing with this back pain, this pain management, and I got lucky with this trial," said Fleck.
He was opioid-free six months after surgery and has been ever since.
"It feels great. My mind's clear, I don't have to live in a fog anymore," said Fleck.
Fifteen successful surgeries and one year of post-operation data finishes Synerfuses' initial quality of care study for FDA approval.
The company is now going to a national randomized clinical trial where it will have 15 to 20 sites all over the country.
Fleck is happy to be back at his construction job and grateful for the surgery.
"It's changed my quality of life. I can get down [to] the ground and play with my grandkids and chase them around now. I feel like a little kid," laughed Fleck.
Dr. Lall and the team at SynerFuse are hoping to fast-track FDA approval of the procedure so it can eventually be covered in the future by insurance and Medicare.
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