Bioness has announced the successful results from the company’s one-year clinical trial of the StimRouter neuromodulation system. The results have been published in Neuromodulation.
The prospective, multicentre, randomised, double-blinded, partial-crossover study assessed the safety and efficacy of the StimRouter neuromodulation system for the treatment of patients with chronic pain of peripheral nerve origin. The StimRouter treatment group achieved primary endpoints of efficacy and safety and demonstrated a statistically significant (p<0.0001) improvement in pain reduction as compared to the control group.
The StimRouter system was granted US Food and Drug clearance in 2015, with indication for pain management in adults with severe intractable chronic pain of peripheral nerve origin, as an adjunct to other therapies. According to Bioness, StimRouter is the only neuromodulation device indicated and marketed to treat chronic pain of peripheral nerve origin.
“I am very pleased to have a minimally invasive peripheral nerve stimulation approach for my patients,” says Timothy R Deer, president and chief executive officer of The Center for Pain Relief in Charlestown, USA. “This is the only device in this category to undergo a prospective Food and Drug Administration monitored study and meet the goals of success. This will be a critical tool for patients going forward, and potentially relieve pain and enhance the quality of life.”
Unlike traditional pain management neuromodulation devices (eg. spinal cord stimulators), StimRouter requires no trial lead, is minimally invasive and performed under local anaesthesia. As a potential cost-effective alternative to injections, ongoing medication regimens and complex surgeries, StimRouter is enabling underserved patient populations to access neuromodulation technology to treat chronic pain. “For decades peripheral nerve stimulation would require implantation of a pulse generator and significant tunnelling from the distal peripheral nerve to the IPG location,” explains William Porter McRoberts, interventional spine and pain management expert. “With the Bioness StimRouter, everything has changed. Tens of thousands of patients are suffering from the painful and disabling condition of post-stroke shoulder pain and now I can implant a single lead along the axillary nerve to treat their pain.”
In addition to meeting the primary efficacy and safety endpoints, the treatment group also showed improvements in activity level, emotional state and quality of life.