Nevro's spinal stimulator offers long-term relief in diabetic neuropathy study

Nevro on Wednesday released new data from a study evaluating the long-term efficacy of its high-frequency 10 kHz spinal cord stimulation (SCS) system for the treatment of refractory painful diabetic neuropathy (PDN). According to the findings, published in the journal Diabetes Research and Clinical Practice, patients who used the FDA-approved Senza HFX system experienced durable pain relief and significant improvements in sleep and health-related quality-of-life (HRQoL) at 24 months post-implantation.

"Compared to previous studies evaluating traditional low-frequency systems for these patients, high-frequency 10 kHz SCS demonstrated greater pain reduction and higher responder rates over time," explained chief medical officer David Caraway. "As we continue gathering data, we expect these results to be used in physician referral decisions and continue to support market access for high-frequency SCS for PDN patients," he added.

The randomised controlled SENZA-PDN trial, which enrolled 216 patients with refractory PDN, compared conventional medical management (CMM) alone with patients receiving both the Senza HFX system and CMM. A total of 142 patients were implanted with the device.

Pain reduced by almost 80%

After 24 months, patients who used the Senza HFX system saw their pain reduced by 79.9% on average, compared to baseline, with 90.1% of users experiencing ≥50% pain relief. Nevro said it also showed benefits for neurological symptoms, with 65.7% of those implanted with the device exhibiting "clinically meaningful improvements" over baseline in sensory, motor or reflex function without worsening in any category. The company noted that the majority of these improvements were in sensory function, which could help restore protective sensation.

Meanwhile, the SCS system also significantly improved HRQoL based on the EuroQol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire. Among those implanted with the device, the mean EQ-5D-5L index value grew by 0.146 from preimplantation to 24 months, almost three to five times the minimally important difference for people with type 2 diabetes, Nevro said. Senza HFX significantly reduced pain interference during sleep as well, demonstrating a 65.5% decrease in the mean Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score, from 6.5 at preimplantation to 1.9 at 24 months.

Nevro said the longer-term data "confirm robust and long-lasting beneficial effects" of the system in patients with PDN.

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