Spinal Modulation said it completed enrollment in a U.S. pivotal study of its Axium neurotransmitter system for the treatment of chronic pain.
The Accurate study is slated to track 152 patients at 22 U.S. sites. Researchers are scheduled to present the clinical trial’s design at the upcoming annual meeting of the North American Neuromodulation Society, to be held in Las Vegas from Dec. 11 to 14. The company also plans to release clinical data at the meeting from studies conducted in Europe and Australia, where the device is already on the market, according to a press release.
Axium is an implantable device that transmits electrical pulses to mask or block pain signals to the brain. Axium differs from similar products because it targets the dorsal root ganglion of the spinal neural system, Spinal Modulation said.
“Approximately 10% to 50% of patients who undergo common procedures like hernia repair, knee surgery and other lower limb surgeries will suffer from chronic pain resulting from nerve injury. These conditions have historically been difficult to treat with currently available technology,” co-principal investigator Dr. Timothy Deer said in prepared remarks. “The Accurate trial is a landmark study that could change the way we treat these chronic pain conditions. Results from prior European studies have been promising, and we are hopeful that the Accurate trial will continue to substantiate the effectiveness of this therapy for our patients."