Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of 24-month data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN, in Diabetes Research and Clinical Practice.
Globally, the number of people with diabetes has quadrupled in the last two decades1, and PDN is one of its most common complications, affecting up to 25 percent of all people with diabetes. PDN symptoms can have a significant impact on quality of life. These symptoms include numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.2 Patients typically manage this complication with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects for patients.3 As a result, people with PDN suffer significantly-reduced health-related quality of life (HRQoL), impaired functionality, and other comorbidities like sleep disorders, depression, and anxiety.4
Published 24-month data from the SENZA-PDN RCT evaluated the long-term efficacy of high-frequency 10 kHz SCS to treat refractory PDN. The data show that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and significant improvements in both HRQoL and sleep at 24 months post-implantation.
Furthermore, most participants experienced neurological symptom improvements, including those in motor, sensory, and reflex function. The long-term data further supports that 10 kHz SCS is a safe and highly effective therapy for PDN, as well as a therapy that demonstrates durable quality of life improvements.
“The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time,” said lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. “These results further validate not only the efficacy of high-frequency 10 kHz SCS for pain relief, but also show profound improvements in quality of life, sleep, and neurological function.”
The SENZA-PDN RCT 24-month data demonstrated the following benefits of 10 kHz SCS Therapy:
Durable Pain Relief
- At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief.
- A DN4 score ≥4 is consistent with clinically confirmed PDN. In the 10 kHz SCS recipients, the proportion with a DN4 score <4 increased significantly from 3.9% at preimplantation to 48.9% at 24 months. (P < .001).
- Investigators assessed neurological function versus study baseline in all implanted patients. At 24 months, 65.7% of implanted patients exhibited clinically meaningful improvements over study baseline in sensory, motor, or reflex function without worsening in any category. A majority of these neurological improvements were in sensory function, which may have implications in restoring protective sensation.
- No other SCS treatment for PDN has exhibited the potentially disease-modifying effects demonstrated by Nevro HFX™ in improving neurological function.
- HRQoL significantly improved with 10 kHz SCS, based on the EuroQol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire.
- Among all implanted patients, the mean EQ-5D-5L index value increased by 0.146 from preimplantation to 24 months, which is 2.9 to 4.9 times the minimally important difference for people with type 2 diabetes.
Pain Interference with Sleep:
- Baseline sleep quality was poor among all study participants, as shown by a mean score on the Pain and Sleep Questionnaire 3-Item Index (PSQ-3; 0-10 cm scale) of 6.5 cm at preimplantation.
- Treatment with 10 kHz SCS significantly reduced pain interference with sleep in the group of all implanted patients over 24 months, as demonstrated by a 65.5% decrease in the mean PSQ-3 score, from 6.5 at preimplantation to 1.9 at 24 months.
- The incidence and type of procedure-related complications were comparable to those reported in the SCS literature for all patient populations. Five (3.2%) SCS systems were explanted due to infection, and no devices were explanted due to lack of efficacy.
- Comparable to the 6- and 12-month SENZA-PDN study outcomes, the 24-month results confirm robust and long-lasting beneficial effects of 10 kHz SCS in PDN patients. These are important findings, given the severe, chronic, and debilitating nature of PDN and the lack of effective treatment options for this patient population.
“We’re encouraged by the latest data demonstrating the long-term efficacy of Nevro HFX to treat the millions of people suffering from PDN worldwide,” said Dr. David Caraway, Nevro’s Chief Medical Officer. “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.5 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.”
Nevro’s SENZA-PDN trial is the largest RCT conducted to date studying SCS therapy for PDN patients, enrolling 216 patients with refractory PDN. In total, 142 patients implanted with Nevro’s high-frequency (10 kHz) SCS system, Nevro HFX, were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone.
This study aimed to provide high-level evidence to aid clinical decision-making, albeit with some limitations, including risks of biased outcomes and potential placebo effects, the potential impact of missed follow-up visits on study results, and limitations related to interpreting the observed neurological improvements.
About Painful Diabetic Neuropathy (PDN)
The World Health Organization estimates 422 million adults live with diabetes worldwide and its prevalence (8.5%) has nearly doubled over four decades.1 Diabetes may cause systemic damage with a profound impact on health-related quality of life and is potentially life-threatening. Diabetic peripheral neuropathy is a common complication presenting as pain and other dysesthesias, including numbness, burning, or tingling. Approximately 20% of patients with diabetes will develop PDN, a progressive, potentially debilitating chronic neuropathic pain condition.6 In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that are refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.7,8