Spinal Modulation, a privately held international medical device company, completed enrollment of the ACCURATE study, a randomized, 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 (SCS), 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 SCS devices, the Axium System uniquely targets the dorsal root ganglion (DRG), 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 centers throughout the United States. This represents the largest neuromodulation study to be conducted in patients suffering from nerve injuries (peripheral causalgia) or complex regional pain syndrome (CRPS, also known as RSD) 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 injury2. These conditions have historically been difficult to treat with currently available technology," said Dr. Timothy Deer, co-study lead and CEO and President of the Center for Pain Relief in Charleston, West Virginia.
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.
The Axium Neurostimulator System is a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain.
The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain. The Axium Neurostimulator System has CE Mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain.