StimRouter: Expanding the Neuromodulation Frontier

Neuromodulation therapies have been used to treat chronic pain dating all the way back to the 1960s¹. The most common therapy is Spinal Cord Stimulation (SCS), which often involves the invasive implantation of an internal pulse generator (IPG) and tunneling lead(s) to the implanted battery. Although SCS is very common, there is a significant lack of neuromodulation therapies indicated specifically for Peripheral Nerve Stimulation (PNS).

StimRouter was exclusively designed to fill this neuromodulation therapy gap by providing a minimally-invasive, long-term treatment option.

Prior to FDA clearance a randomized, double-blinded, partial crossover study was conducted to determine product efficacy and safety. Ninety four (n=94) subjects with chronic peripheral nerve pain in the upper extremity, lower extremity or trunk, were implanted with the StimRouter Neuromodulation System.

Clinical Study Results²

Primary Safety Endpoint was defined by the FDA as a 30% decrease in pain using the StimRouter without an increase in pain medicine.

  • The responder rate was statistically higher for the treatment group when compared to the control group for all areas (UE, LE and trunk) at a statistical significance of p<0.0001.

Primary Safety Endpoint defined as no severe adverse events related to the device.

  • Over a 12-month year period zero (0) severe adverse events were reported related to StimRouter.

Secondary Efficacy Endpoints

Percent Reduction in Secondary Pain Efficacy Measures (p<0.0001)

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  • The treatment group had a significantly better improvement than the control group in quality of life; patient global impression of change in activity limitations, symptoms, emotions and overall quality of life related to the painful condition.
  • Over 50% of the treatment group rated their satisfaction at 8 or higher on a 10-point scale, with 0 indicating not satisfied at all and 10 indicating completely satisfied.
  • 53% of the treatment group rated their global impression of change in activity limitations, symptoms, emotions and overall quality of life related to their painful condition between 5-7 on a 7-point scale with 7 indicating considerable improvement and 1 indicating no change.

PNS versus SCS

  • Few studies exist on PNS devices; they are not the same as spinal cord stimulators.
  • Statistical significance and study design were created based on FDA requirements.
  • Comparative variability of the patient population in PNS is much higher than SCS given the diverse etiologies, pathology mechanisms and diverse implant locations.
  • 19 different peripheral nerves were implanted in the StimRouter Clinical Study.

Overall The StimRouter Neuromodulation System:

  • Provides clinically-relevant pain relief.
  • Is safe for use in patients suffering from chronic pain of peripheral nerve origin.
  • Performs significantly better in secondary outcomes, which include percent of pain reduction, quality of life, patient global impression of change, and patient satisfaction, when compared to the Control group of similar subjects receiving no stimulation.
  • Achieved the study’s pre-specified primary efficacy endpoint while maintaining an excellent safety profile.