The Senza spinal cord stimulation (SCS) system, a new device for the management of chronic intractable trunk or limb pain, was given approval from the FDA.
Unlike previously approved implanted spinal cord simulators, the Senza system delivers a high frequency output of 10 kHz without paresthesia. Prior to implantation, patients undergo a 1- to 2-week simulation with an external model to determine the stimulation’s effectiveness on a personalized basis.
The FDA approval came following a randomized, controlled safety and efficacy study of 198 subjects, 97 of whom were assigned to another FDA-approved stimulation device.
At 3 months, 75% of patients treated with the Senza System reported a 50% reduction in pain from baseline. At 12 months, the average pain reduction reached 55%. No stimulation-related neurological deficits, including weakness in the limbs or tremors, were reported for either treatment group.
Citation: FDA approves spinal cord stimulation system that treats pain without tingling sensation. FDA Website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm446354.htm. Published May 8, 2015. Accessed May 18, 2015.