Spinal Modulation has completed enrolment of the ACCURATE study, a randomised, controlled pivotal clinical trial designed to evaluate the safety and efficacy of the company’s Axium neurostimulator system.
The Axium system is a targeted form of spinal cord stimulation, which uses an implantable medical device to deliver mild electrical pulses that mask or interrupt pain signals as they travel from the periphery to the brain. Unlike traditional spinal cord stimulation devices, Axium uniquely targets the dorsal root ganglion, a neural structure within the spine that has been shown to play a critical role in the development and maintenance of chronic pain.
The ACCURATE study enrolled 152 patients at 22 centres throughout the USA. This represents the largest neuromodulation study to be conducted in patients suffering from nerve injuries or complex regional pain syndrome to date.
“Approximately 10-50% 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,” says Timothy Deer, co-study lead and chief executive officer and president of the Center for Pain Relief in Charleston, West Virginia. “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.”
Investigators will present the ACCURATE trial design at the 18th Annual North American Neuromodulation Society (NANS) meeting in Las Vegas, Nevada, December 11 – 14, 2014. Clinical outcomes from Europe and Australia, where the Axium system is commercially available, will also be presented.