Bioness, Inc, Valencia, Calif, recently announced what it characterizes as “the successful results” from the company’s 1-year clinical trial of the StimRouter Neuromodulation System. The results have been published in the January issue of Neuromodulation.
The prospective, multi-center, randomized, double blinded, partial crossover study assessed safety and efficacy of the StimRouter Neuromodulation System for the treatment of patients with chronic pain of peripheral nerve origin. The StimRouter Treatment Group reportedly 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.
StimRouter received clearance from the Food and Drug Administration (FDA) last year and is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy. According to a media release from Bioness, StimRouter is the only implantable 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, MD, president and chief executive officer of The Center for Pain Relief in Charlestown, WVa. “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.”
Bioness reports that in contrast traditional pain management neuromodulation devices (eg, spinal cord stimulators), StimRouter requires no trial lead, is minimally invasive, and performed under local anesthesia. As a potential cost-effective alternative to injections, ongoing medication regimens, and complex surgeries, StimRouter is designed to enable 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 tunneling from the distal peripheral nerve to the IPG location,” explains William Porter McRoberts, MD, in a media release from Bioness. McRoberts is described in the release as an 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,” McRoberts states.
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. “These long-term results reveal that the StimRouter Neuromodulation System provides a clinically significant and sustaining pain management solution,” stated Todd Cushman, president and chief executive officer of Bioness. “These clinical trial results enhance and further our goal of expanding StimRouter accessibility in pain management and rehabilitation.”