A groundbreaking surgical implant developed in Minnesota for treating chronic back pain has reached a significant milestone on its path to FDA approval, offering hope to millions suffering from debilitating spinal conditions.
SynerFuse, created by specialists from the University of Minnesota and M Health Fairview, represents the world's first double infusion implant that combines traditional spine surgery with nerve stimulation technology. The device has completed its initial quality of care study with 15 successful surgeries and one year of post-operation data.
How SynerFuse Works
The innovative procedure integrates conventional spinal surgery techniques with targeted nerve stimulation to address chronic back pain at its source.
"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," explained Dr. Rohan Lall, neurosurgeon at M Health Fairview.
These nerve stimulators fundamentally alter the nerve's ability to transmit pain signals to the brain. Patients can control the stimulation parameters using a smartphone application, allowing them to adjust the strength of stimulation to specific nerve roots as needed throughout the day.
Patient Success Stories
Jason Fleck, a construction tradesman from Hillman, Minnesota, represents one of the procedure's success stories. After a work-related injury in 2022 left him barely able to walk, Fleck enrolled in the SynerFuse clinical trial.
"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," Fleck recalled.
Unlike his previous back surgeries that required lengthy recoveries and prolonged opioid use, Fleck was completely opioid-free within six months of his SynerFuse procedure.
"It feels great. My mind's clear, I don't have to live in a fog anymore," said Fleck. "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."
Addressing the Opioid Crisis
The SynerFuse technology addresses two critical healthcare challenges: chronic back pain management and opioid dependence. Back pain remains one of the leading causes of disability worldwide, with conventional treatments often relying heavily on opioid medications for pain control.
By providing an alternative pain management approach that doesn't require opioids, SynerFuse could potentially help reduce opioid prescriptions for chronic pain patients. Fleck's experience exemplifies this benefit, as he had previously been dependent on opioid medications for approximately two years before receiving the implant.
Path to FDA Approval
With the initial quality of care study now complete, SynerFuse is advancing to the next phase of clinical evaluation. The company is launching a national randomized clinical trial that will include 15 to 20 sites across the United States.
Dr. Lall and the SynerFuse team are pursuing fast-track FDA approval for the procedure, which would accelerate its availability to patients. The ultimate goal is to secure coverage from insurance providers and Medicare, making the technology accessible to a broader patient population.
Technical Innovation
The SynerFuse system represents a significant advancement in neuromodulation technology for pain management. Unlike traditional spinal cord stimulators that target the dorsal columns, SynerFuse directly stimulates the nerve roots that are causing pain.
Patients control their therapy through a dedicated smartphone application, which allows them to select specific nerve roots (such as L4 or L5) and adjust stimulation parameters based on their pain levels and activities.
This personalized approach to pain management gives patients greater control over their treatment while potentially reducing the need for pharmaceutical interventions and their associated side effects.
As SynerFuse progresses through clinical trials and regulatory review, it offers new hope for the millions of Americans suffering from chronic back pain who have not found adequate relief through conventional treatments.
