The Spinal Modulation Neurostimulator system (Spinal Modulation) has received CE mark for the management of chronic intractable pain. This system utilises low-level electrical signals to modulate neural structures of primary sensory neurons located within the dorsal root ganglion. These cell bodies have been implicated in the development and maintenance of chronic pain conditions.
Liong Liem and Paul Verrills presented the initial results of the world’s first multicentre prospective clinical trial to assess the management of chronic pain through stimulation of the dorsal root at the 15th Annual North American Neuromodulation Society (NANS) conference in Las Vegas, USA.
“The Spinal Modulation system has provided substantial benefit to a number of my patients with chronic intractable pain that have not had adequate pain relief with other spinal cord stimulation systems. For example, patients with chronic intractable pain in the lower extremities are typically very difficult to treat with existing spinal cord stimulation systems. With the Spinal Modulation system, I have seen very encouraging results in patients with this type of pain condition,” said Liem, director of the Pain Management Practice at Sint Antonius Hospital in The Netherlands.
Neurostimulation therapy is a proven method of managing chronic pain. It uses an implantable medical device to deliver mild electrical pulses to neural tissue to mask or interrupt pain signals as they travel to the brain. With dorsal column spinal cord stimulation, small wires are placed along the midline of the epidural space. With the Spinal Modulation therapy, physicians place a specialised neuromodulation system in the epidural space to target the dorsal root ganglion, which allows the signals to be masked or interrupted even before they enter the spinal cord.
“Spinal Modulation has taken a deliberate and scientific approach to developing this therapy. My practice has partnered with Spinal Modulation to help demonstrate the clinical utility of neuromodulation of the dorsal root ganglion in patients with chronic, intractable pain. I am very enthusiastic that they have developed practical and clinically useful tools for long-term stimulation of the dorsal root ganglion and I look forward to its commercial availability in my practice in Australia,” said Marc Russo, Director of the Hunter Pain Clinic in Newcastle, Australia.
The company has begun international commercialisation and plans to continue clinical research in order to advance dorsal root ganglion stimulation and provide pain relief for more patients.
The Spinal Modulation Neurostimulator system is not approved for use or sale in the United States.