Spinal Modulation Enrolls First Patient in U.S. Pivotal Study of the Investigational Axium Neurostimulator System for Chronic Pain
ACCURATE Study Will Evaluate Innovative Spinal Cord Stimulation Therapy Designed to Provide Targeted Relief of Chronic Lower Limb Pain.
Spinal Modulation, Inc., a privately held global medical device company, today announced the first patient enrollment in its U.S. pivotal clinical trial. The ACCURATE study is a prospective, randomized, multi-center, controlled trial that will evaluate the safety and efficacy of the Axium™ Neurostimulator System for the treatment of chronic lower limb pain. This announcement was made as industry leaders convened last week at the 20th Annual Napa Pain Conference, where data were presented about European experience with the Axium System.
“This is a landmark study in the field of spinal cord stimulation,” said Eric Grigsby, M.D., founder and medical director of the Napa Pain Institute and the center’s Principal Investigator. “The Axium System targets the dorsal root ganglion (DRG), a unique branch of the spinal cord that plays a critical role in the development and maintenance of chronic pain Pope JE, Deer TR, Kramer J. A Systematic Review: Current and Future Directions of Dorsal Root Ganglion Therapeutics to Treat Chronic Pain. Pain Medicine. 2013.. The recently published European data Liem et al. A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain. Neuromodulation. 2013. from a non-randomized study are promising – 78 percent of patients experienced pain relief in the lower limbs. I am excited to be the first in the country to participate in this important clinical trial.” The study is expected to enroll 152 patients in up to 25 medical centers in the U.S.
The ACCURATE study will enroll patients with chronic lower limb pain caused by Complex Regional Pain Syndrome (CRPS) or nerve damage (peripheral causalgia). “Chronic post-surgical pain is a major unaddressed need. Up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations suffer from chronic post-surgical pain Macrae, W.A. Chronic post-surgical pain: 10 years on. British Journal of Anaesthesia. 2008. The Axium Neurostimulator System can potentially expand treatment options for this large underserved patient group,” said Tim Deer, M.D., co-study lead and president-elect of the International Neuromodulation Society.