Spinal Modulation has enrolled the first patient in ACCURATE study, a prospective, randomized, multi-center, controlled trial designed to evaluate the safety and efficacy of the Axium neurostimulator system for the treatment of chronic lower limb pain.
The company made this announcement last week at the 20th annual Napa Pain Conference, where data were presented about European experience with the Axium system.
The study is expected to enroll 152 patients in up to 25 medical centers in the US.
The ACCURATE study will enroll patients with chronic lower limb pain caused by complex regional pain syndrome (CRPS) or nerve damage (peripheral causalgia).
Napa Pain Institute founder and medical director and the center’s principal investigator Dr Eric Grigsby noted the trial as a landmark study in the field of spinal cord stimulation.
"The recently published European data from a non-randomized study are promising – 78 percent of patients experienced pain relief in the lower limbs," Dr Grigsby added.
The Axium system targets the dorsal root ganglion region of the spinal cord that plays a vital role in the development and maintenance of chronic pain.
The Axium system which is designed to provide targeted relief for chronic lower limb pain, has CE Mark in the EU and TGA approval in Australia.