Categories: CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Nevro Announces Three Important Clinical Data Publications for Treating Painful Diabetic Neuropathy with 10 kHz Therapy

Findings from all three studies highlight the significant benefits of HFX™ for PDN¹ in the clinical and real-world settings.  HFX for PDN is the only spinal cord stimulation (SCS) system approved by the U.S. Food and Drug Administration with a specific on-label indication for treating PDN.
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Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced three important clinical data publications for treating Painful Diabetic Neuropathy (PDN) with 10 kHz Therapy, including 12-month data from the landmark SENZA-PDN Randomized Controlled Trial (RCT) published online in Diabetes Care, as well as real-world evidence and a comparative literature review of high vs. low frequency SCS evidence, both published in the Journal of Diabetes Science and Technology.

Findings from all three studies highlight the significant benefits of HFX™ for PDN¹ in the clinical and real-world settings.  HFX for PDN is the only spinal cord stimulation (SCS) system approved by the U.S. Food and Drug Administration with a specific on-label indication for treating PDN.

“These three important clinical data publications further expand the growing body of positive clinical evidence supporting the use of 10 kHz Therapy in treating PDN patients and continue to clearly demonstrate the safety, durability and consistency of pain relief and other outcomes that can be achieved with HFX for PDN in both clinical and real world settings,” said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro.  “No conventional, low-frequency SCS treatments have demonstrated such positive results in treating PDN patients.  We believe that these data, along with our robust clinical dossier, will help support expansion of payer coverage policies to exclusively cover 10 kHz Therapy for PDN.  These data highlight our commitment to deliver comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment.”

12-Month SENZA-PDN RCT Results

Published 12-month data from the SENZA-PDN RCT, the largest RCT to evaluate SCS to treat PDN, showed that high-frequency 10 kHz Therapy results in significant, durable pain relief and neurological improvements in patients with persistent PDN.²  The publication also includes results for patients before and after crossover from the Conventional Medical Management (CMM) arm to 10 kHz Therapy. These findings further substantiate the benefit of HFX for PDN, a Senza SCS system that uses 10 kHz Therapy to treat pain from diabetic neuropathy.

Diabetes Care publication can be accessed online (subscription required) at:  https://care.diabetesjournals.org/lookup/doi/10.2337/dc21-1813

“Patients with painful diabetic neuropathy have no way to cure their condition, and many have trouble achieving relief from their pain,” said Dr. Erika Petersen, Professor of Neurosurgery, Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, and lead investigator of the SENZA-PDN study. “However, with high-frequency 10 kHz Therapy, I’m seeing durable pain relief and potentially disease-modifying neurological improvements, which could be a game-changer when it comes to how we treat patients with impaired sensory function.”

The SENZA-PDN RCT 12-month data demonstrated the following benefits of 10 kHz SCS:

Durable Pain Relief:

  • At 12 months, 86% of participants in the 10 kHz SCS study arm reported pain relief >50%, while the average pain relief was 77.1% (% reduction of VAS from baseline).
  • After six months with 10 kHz SCS therapy, 84% of participants in the crossover arm reported pain relief >50%, and average pain relief was 70.3% (% reduction of VAS from baseline).

Consistent Safety:

  • Safety was consistent with published reports of adverse event rates in traditional SCS trials, including for infections and explants in people without diabetes.3,4,5
  • Only 5 of 154 permanent SCS devices were explanted for a 3.2% explant rate (all explants were due to infection).

Neurological Improvement:

  • At 12 months, 68% of the 10 kHz SCS treatment group had observed improvement upon an investigator-assessed neurological examination, which included testing lower limb motor strength, sensory function, and reflexes.
  • After six months with 10 kHz SCS therapy, 62% of the crossover arm had observed improvement upon an investigator-assessed neurological examination, which included testing lower limb motor strength, sensory function, and reflexes.

Real-World Evidence for Treatment of PDN

Published in the Journal of Diabetes Science and Technology, “A Real-World Analysis of High-Frequency 10 kHz Spinal Cord Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy” is a retrospective, multi-center, real-world review in typical clinical practices that assessed pain relief and functional improvements for patients who were trialed and permanently implanted with a 10 kHz SCS device.6  This data was extracted from a real-world database of patients (HFX Cloud™) with diabetic neuropathy.

Journal of Diabetes Science and Technology publication can be accessed online (subscription required) at: https://doi.org/10.1177/19322968211060316

Results from this real-world review demonstrated:

  • 79.5% (58/73) of patients were treatment responders, defined as having at least 50% patient-reported pain relief from baseline.
  • Average follow-up was 21.8 months (range: 4.3 to 46.3 months)
  • Majority of patients reported improvements in sleep and overall function relative to their baseline

High-Frequency vs Low-Frequency SCS in PDN

Also published in the Journal of Diabetes Science and Technology, “Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation” is a comparative literature review that evaluated current evidence for both high-frequency and low-frequency SCS to treat PDN.7

Journal of Diabetes Science and Technology publication can be accessed online (subscription required) at: https://doi.org/10.1177/19322968211060075

The analysis concluded that high-frequency (10 kHz) SCS offers several advantages over low-frequency, paresthesia-dependent SCS, including:

  • Greater pain relief
  • A higher proportion of patients achieving treatment success
  • Paresthesia-free
  • Evidence of improved neurological function