The Food and Drug Administration (FDA) has expanded the approval of Nevro’s Senza® Spinal Cord Stimulation (SCS) System to include treatment of nonsurgical refractory back pain.
The Senza SCS System is a neuromodulation device designed to deliver electrical stimulation using implantable leads and a rechargeable, implantable pulse generator. It was previously approved for use in the management of chronic intractable pain of the truck and/or limbs.
The new approval was based on data from a randomized clinical trial (ClinicalTrials.gov Identifier: NCT03680846) that included 159 patients diagnosed with chronic, refractory axial low back pain with a neuropathic component who were not eligible for spine surgery. The study compared Nevro’s high frequency (10kHz) SCS plus conventional medical management (CMM) to CMM alone.
The primary endpoint was the difference between treatment groups in responder rates, defined as patients who have at least a 50% reduction in pain from baseline as assessed by the visual analog scale.
Results at 12 months showed that the trial met its primary endpoint (P <.001). Moreover, patients treated with the 10kHz therapy were found to have significant improvements in pain relief, function, and quality of life; a reduction in daily opioid use was also observed. Comparable improvements were also seen in those who crossed over from CMM to 10kHz therapy after 6 months.
“Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery,” said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. “This FDA approval marks another milestone in Nevro’s commitment to expanding access to 10 kHz therapy for these underserved patients.”
- Nevro announces FDA approval for expanded labeling for its 10 kHz high frequency spinal cord stimulation system for treatment of nonsurgical refractory back pain (NSRBP). News release. Accessed January 19, 2022. https://www.prnewswire.com/news-releases/nevro-announces-fda-approval-for-expanded-labeling-for-its-10-khz-high-frequency-spinal-cord-stimulation-system-for-treatment-of-non-surgical-refractory-back-pain-nsrbp-301463580.html
- Clinical data presented at 2022 North American Neuromodulation Society (NANS) Annual Meeting reinforce significant and durable benefits of Nevro’s 10 kHz therapy. News release. January 18, 2022. Accessed January 19, 2022. https://www.nevro.com/English/us/investors/investor-news/investor-news-details/2022/Clinical-Data-Presented-at-2022-North-American-Neuromodulation-Society-NANS-Annual-Meeting-Reinforce-Significant-and-Durable-Benefits-of-Nevros-10-kHz-Therapy/default.aspx
- Senza, Senza II, Senza Omnia. Physician implant manual. Accessed January 19, 2022. https://s28.q4cdn.com/260621474/files/doc_downloads/physician_manual/2021/07/Physician-Implant-Manual-(11051).pdf