Spinal Fusion/Stimulation Trial for Back Pain Underway

(NIH.gov)

14 Jan. 2021. A clinical trial is underway testing an implanted device providing electronic stimulation along with spinal fusion surgery to treat chronic lower back pain. SynerFuse Inc. in Minneapolis, developer of the device and sponsor of the trial at University of Minnesota Medical Center, says surgeons implanted the device in the study’s first participant.

The SynerFuse device is designed to provide electronic stimulation, called neuromodulation, to patients with chronic lower back pain. The company says in most cases today, patients with lower back pain receive spinal fusion surgery, a procedure where two or more vertebrae in the spine are fused together to reduce motion and improve stability of the spine to reduce pain. SynerFuse says multiple fusion surgeries are often needed, interspersed with opioid drugs prescribed for pain relief, with neuromodulation sometimes added later on.

As an alternative, says the company, the SynerFuse device is implanted by surgeons at the same time as the first spinal fusion to bring more immediate pain relief. The device sends out electronic pulses that stimulate the dorsal root ganglion, a network of nerve cells in the spinal column that carry sensory signals into the central nervous system, and are associated with neuropathic pain.

Permanent implant controlled by the patient

The implant is based on neuromodulation technology made by Cirtec Medical in Brooklyn Park, Minnesota, and adapted for spinal implants. The combination of neuromodulation with initial spinal fusion surgery is expected to provide faster pain relief and reduce the need for opioid pain killers. In response to a question from Science & Enterprise, SynerFuse says the device implant is permanent, and can be adjusted by the patient with a wireless handheld controller.

The clinical trial appears to be an early-stage study assessing the SynerFuse device’s safety and tolerability, as well as the feasibility of implanting the device at the same time as spinal fusion surgery. The study team at University of Minnesota plan to enroll up to 20 participants, patients undergoing spinal fusion surgery. The company says the Food and Drug Administration granted an investigational device exemption to allow the trial to begin, and findings from the trial will help prove the SynerFuse device concept of combining neuromodulation with spinal fusion surgery.

The SynerFuse device is based on research by the company’s co-founder Gregory Molnar, professor of neurology at University of Minnesota. Molnar is also the company’s chief scientist. SynerFuse was officially founded in 2015, but much its research and development activity, including collaboration with Cirtec Medical, has taken place in the past year.

“The implantation of the first patient in our proof-of-concept study,” says company CEO Justin Zenanko in a statement released through Cision, “is an important milestone for SynerFuse. “We’re one step closer to demonstrating the viability of our non-narcotic solution for spinal fusion patients with chronic lower back pain.”

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