Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.
Data from previous European clinical studies suggest that Nevro’s proprietary high-frequency waveform may be effective in treating low back pain and other challenging types of chronic pain that often do not respond to conventional spinal cord stimulation. Data also show that Nevro’s technology can deliver pain relief without paresthesia, which has allowed many patients in countries where the system is available to experience, for the first time, true relief from chronic pain without unpleasant side effects.
According to the announcement, “There is a real, unmet need for additional treatment options for chronic pain patients,” said Leonardo Kapural, M.D., Ph.D, medical director of Wake Forest University Health Sciences, Chronic Pain Center in Winston-Salem, N.C., who serves as the principal investigator for the SENZA-RCT trial. “Early studies suggest that high-frequency spinal cord stimulation may expand the group of patients treatable with spinal cord stimulation therapy while eliminating paresthesia, a highly unpleasant side effect of current systems. If these benefits are confirmed in the SENZA-RCT study, Nevro’s high-frequency spinal cord stimulation system could represent an important breakthrough in the management of chronic pain.”