Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the complete 12-month results from the SENZA-PDN Randomized Controlled Trial (RCT), including health-related quality of life (HRQoL) outcomes in patients with Painful Diabetic Neuropathy (PDN) treated with high-frequency 10 kHz spinal cord stimulation (SCS), were published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes.
“In addition to the strong clinical efficacy for HFX Therapy that has already been shown in our landmark SENZA-PDN trial, these results demonstrate improvement in several important health-related quality of life metrics in patients with PDN,” said D. Keith Grossman, Chairman, CEO and President of Nevro. “Coupled with previously reported data that showed substantial pain relief and neurological improvements at 12 and 24 months, these data will be used to support physician referral decisions as well as our ongoing market access initiatives to expand payer coverage for this patient population.”
High-Frequency 10 kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients with Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial
The published data in the Mayo Clinic Proceedings showed treatment with 10 kHz Therapy resulted in significant pain relief and multiple significantly improved metrics of HRQoL. Results included significantly less pain interference with sleep, mood, and daily activities. Importantly, at 12 months, 10 kHz SCS treatment resulted in improvement in overall HRQoL that was 2.5- to 4.5-fold higher than the minimally clinically important difference. Furthermore, over 70% of clinicians and patients reported overall improvement as better or a great deal better than the pre-SCS baseline. These outcomes were durable over 12 months and support 10 kHz SCS treatment in patients with refractory painful diabetic neuropathy. In addition, approximately 92% of participants were satisfied or very satisfied with 10 kHz Therapy.
This paper can be accessed at: https://www.sciencedirect.com/science/article/pii/S2542454822000297.
Current treatment options remain inadequate for many patients suffering from PDN, a condition that is associated with pain in the extremities and diminished sleep quality and quality of life, resulting in large unmet needs. The SENZA-PDN study is the largest RCT conducted to date for SCS treatment of PDN. Compared with pharmacotherapy, high-frequency 10 kHz SCS resulted in more profound pain relief and pronounced HRQoL improvements, including well-being, sleep quality and function.
Previously published 12-month results in Diabetes Care demonstrated significantly improved and sustained outcomes with high-frequency 10 kHz Therapy, including substantial, sustained pain relief and improved health-related quality of life in patients suffering from PDN.¹ The company expects the complete 24-month data from the SENZA-PDN RCT to be available in the fourth quarter of 2022 and plans to submit this data set for presentation at NANS in January 2023 and publish as soon possible thereafter.
About Painful Diabetic Neuropathy (PDN): The World Health Organization estimates 422 million adults with diabetes worldwide and prevalence (8.5%) that has nearly doubled over four decades.2 Diabetes may cause systemic damage with 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.3 In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that become refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.4,5