Nevro's high-frequency neurostimulation cuts diabetic neuropathy pain by 80% in 2-year study

Two years after a high-frequency version of Nevro’s neurostimulation system became the first spinal cord stimulator approved by the FDA with a specific indication to treat pain associated with diabetic neuropathy, the company has published long-term study data further backing up the regulator’s decision.

The study spanned two years and enrolled more than 200 people with painful diabetic neuropathy, and its results were published recently in the journal Diabetes Research and Clinical Practice, the company announced Wednesday.

Throughout the study period, a total of 142 of the participants were implanted with the high-frequency version of Nevro’s Senza system. It’s implanted near the spinal cord and operates at a frequency of 10 kHz—allowing it to send 10,000 electric pulses per second to a patient’s nervous system, with an aim of interrupting pain signals as they travel to the brain.

Not only does Nevro’s system operate at a significantly higher frequency than many of its competitors’ spinal cord stimulators, but the company also claims that the HFZ approach eliminates the uncomfortable tingling and buzzing sensations associated with lower-frequency neurostimulation.

The Senza system is rechargeable, with a battery designed to last up to 10 years.

Diabetic neuropathy affects about a quarter of all people with diabetes, according to statistics cited by Nevro, with often-painful symptoms including numbness, tingling, balance issues and a reduced response to sensory stimuli, among others.

The symptoms are typically treated with oral pain medications, which may not be overwhelmingly effective and can spark painful or otherwise debilitating side effects of their own, the company noted.

Meanwhile, after 24 months, users of the Senza system experienced an average pain reduction of 79.9%, and just over 90% of the study’s participants saw their pain levels slashed at least in half after being implanted with the neurostimulation device.

Beyond pain relief, Nevro’s technology also helped improve participants’ overall health-related quality of life. In the latter metric, the implanted patients saw an average improvement of 0.146 on the standard EuroQol 5-Dimension 5-Level scale, which is about three to five times higher than the minimal important difference specified for people with Type 2 diabetes.

They also reported boosts in neurological function: By the end of the study, about two-thirds of the participants were showing clinically meaningful improvements compared to their baseline neurological function. The majority of those improvements fell under the sensory function category, which Nevro said suggests that its technology could help restore protective sensation in people with painful diabetic neuropathy.

Throughout the two-year study period, five of the Senza systems—representing about 3% of those implanted in the study—had to be removed due to infection, the company reported, but none were removed because they weren’t working.

The data suggest that the high-frequency Senza system is a “viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time,” Erika Petersen, M.D., lead principal investigator of the study, said in this week’s announcement.

David Caraway, M.D., Ph.D., Nevro’s chief medical officer, added that the company is expecting the promising study results—along with those from future planned studies—to boost physician referrals for Nevro’s therapy and to “continue to support market access for high-frequency SCS for PDN patients.”