The Food and Drug Administration (FDA) has approved the Senza® Omnia spinal cord stimulation (SCS) system for the treatment of chronic pain associated with painful diabetic neuropathy (PDN).
The Omnia SCS system uses 10kHz therapy to deliver mild electrical pulses directly to inhibitory neurons in the dorsal horn, providing pain relief without paresthesia. The approval is supported by data from the prospective, multicenter, open-label, randomized SENZA-PDN trial (ClinicalTrials.gov Identifier: NCT03228420), which compared 10kHz SCS plus conventional medical management (CMM) to CMM alone in patients with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy.
The primary endpoint of the study was the percentage of patients with at least a 50% reduction in lower limb pain from baseline as measured by a 10cm visual analogue scale (VAS), without worsening of baseline neurological deficits at 3 months.
Results showed that among the intention-to-treat population, 79% (n=75/95) of patients in the 10kHz SCS plus CMM arm achieved substantial pain relief and met the primary endpoint compared with 5% (n=5/94) of those in the CMM arm (difference, 73.6%; 95% CI, 64.2-83.0; P <.001). Mean pain VAS scores in the 10kHz SCS plus CMM arm at baseline and at 6 months were 7.6cm (95% CI, 7.3-7.9) and 1.7cm (95% CI, 1.3-2.1), respectively. Mean pain VAS scores in the CMM arm at baseline and at 6 months were 7.0cm (95% CI, 6.7-7.3) and 6.9cm (95% CI, 6.5-7.3), respectively. At 6 months, improvement in neurological examination was observed in 62% (n=52/84) of patients in the 10kHz SCS arm and 3% (n=3/92) of those in the CMM group (difference, 58.6%; 95% CI, 47.6-69.6; P <.001).
At a 12-month follow-up, durable pain relief and improved quality of life were demonstrated with 10kHz SCS treatment. Most patients also showed improvements on neurological examination.
Nevro’s SCS system for painful diabetic neuropathy will be available under the brand name HFX™ for PDN.
- Nevro announces FDA approval of its 10 kHz high frequency spinal cord stimulation therapy for treatment of chronic pain associated with painful diabetic neuropathy (PDN). News release. Nevro Corp. Accessed July 19, 2021. https://www.prnewswire.com/news-releases/nevro-announces-fda-approval-of-its-10-khz-high-frequency-spinal-cord-stimulation-therapy-for-treatment-of-chronic-pain-associated-with-painful-diabetic-neuropathy-pdn-301336018.html.
- Petersen EA, Stauss TG, Scowcroft JA, et. al. Effect of high-frequency (10-kHz) spinal cord stimulation in patients with painful diabetic neuropathy: A randomized clinical trial. JAMA Neurol. 2021;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
- Petersen EA, Scowcroft JA, Brooks ES, et al. Long-term 10 kHz spinal cord stimulation in painful diabetic neuropathy: A randomized controlled trial. Late-breaking poster session presented at: American Diabetes Association 81st Scientific Sessions; 2021 Jun 25-29; Virtual.