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).
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.
Primary Safety Endpoint was defined by the FDA as a 30% decrease in pain using the StimRouter without an increase in pain medicine.
Primary Safety Endpoint defined as no severe adverse events related to the device.
Percent Reduction in Secondary Pain Efficacy Measures (p<0.0001)
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