Nevro, a company based in Menlo Park, California, won FDA approval for its Senza spinal cord stimulation system. The Senza delivers Nevro’s proprietary HF10 therapy to help control chronic pain of the trunk and lower extremities resulting from a variety of conditions, including failed spinal surgeries.

The implantable device, as the name implies, delivers high frequency electrical signals at 10kHz, considerably greater than other neurostimulators. This prevents the therapy from producing side effects such as paresthesias and does not limit patients from driving their cars. Moreover, patients can still receive MRI scans while wearing the implant, given certain precautions.

The system has been approved in Europe and Australia, including for safety while under MRI, and has been in use for the last five years.

The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to directly compare SCS therapies. The multicenter study was conducted across 11 U.S. clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomized SCS study ever conducted to assess the treatment of chronic back and leg pain.

The labeling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional SCS therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes. Superiority was demonstrated in the primary and all secondary endpoints including at every measurement time point throughout the 12 month follow up.

source:Nevro