Spinal Modulation has enrolled the first patient in US pivotal study of the investigational Axium neurostimulator system for chronic pain.
The ACCURATE study is a prospective, randomised, multi-centre, controlled trial designed to evaluate the safety and efficacy of the Axium neurostimulator system for the treatment of chronic lower limb pain.
It will enrol patients with chronic lower limb pain caused by complex regional pain syndrome or nerve damage (peripheral causalgia).
The study is expected to enrol 152 patients in up to 25 medical centres in the US.
Napa Pain Institute founder and medical director and the centre’s principal investigator Dr Eric Grigsby said the trial was a landmark study in the field of spinal cord stimulation.
"The recently published European data from a non-randomised study are promising, 78% of patients experienced pain relief in the lower limbs," Dr Grigsby said.
The Axium neurostimulator system targets the dorsal root ganglion (DRG), a specific branch of the spinal cord that plays a critical role in the development and maintenance of chronic pain.
The system uses an implantable medical device to deliver mild electrical pulses to the DRG, which contains the primary sensory neurons that transmit pain signals to brain from the peripheral nerves. These mild electrical pulses replace the pain signals as they travel to the brain.
The International Neuromodulation Society president-elect and co-study lead Dr Tim Deer said that chronic post-surgical pain was a major need that needed addressing. Up to 35% of patients who undergo hernia surgery and 50%-85% of patients who undergo amputations suffer from chronic post-surgical pain.
"The Axium neurostimulator system can potentially expand treatment options for this large underserved patient group," Dr Deer said.
The Axium neurostimulator system previously received CE mark and Therapeutic Goods Administration (TGA) approval in Australia for the management of chronic, intractable pain.
According to GlobalData estimates, spinal cord stimulators market in the US was valued at $1.13bn in 2012 and is expected to grow at a CAGR of 9.2% to reach $2.1bn by 2019.