Nevro Corporation has announced the results from data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions (3–7 June 2022, New Orleans, USA) supporting the use of 10kHz spinal cord stimulation (SCS) therapy for patients with chronic pain, including results from the SENZA painful diabetic neuropathy (PDN) randomised controlled trial (RCT).
Results were presented on Sunday 5 June by the study’s lead principal investigator Erika Petersen (University of Arkansas for Medical Sciences, Little Rock, USA).
“At this year’s ADA Scientific Sessions, we were excited to share for the first time the 24-month results from the 10kHz arm of our landmark SENZA-PDN trial, which continue to clearly demonstrate the safety, durability and consistency of pain relief and other outcomes that can be achieved with HFX for PDN,” said Keith Grossman, chairman, CEO and president of Nevro.
“While prior research has looked at the benefit of SCS for treating pain related to diabetic neuropathy, this is the first time that neurological improvement after SCS was studied. No traditional, low-frequency SCS treatments have demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to expand this innovative treatment option to PDN patients who are unable to find relief with currently available pharmacologic options.”
The data presented at the ADA 82nd Scientific Sessions highlighted 24-month results for the original 10kHz arm of the SENZA-PDN trial—the largest PDN RCT of SCS treatment conducted to date, according to Nevro, with 216 randomised subjects at 18 US centres. Key findings at 24 months, presented by Petersen, included significant and sustained outcomes with 10kHz SCS, such as:
- Responder rate: 84%
- Substantial pain relief: 77% average reduction in pain, consistent over 24 months
- Improved sleep: 69% average reduction in sleep disturbance
- Improved quality of life: Average improvement is three times the minimal clinically important difference (MCID)
- Improved sensory function: 71% sensory improvement rate
- High patient satisfaction: 89% very satisfied or satisfied
- No explants were required for loss of efficacy
Previously published complete 12-month results in Diabetes Care demonstrated significantly improved and sustained outcomes with high-frequency 10kHz therapy, including substantial, sustained pain relief and improved health-related quality of life in patients suffering from PDN. 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 dataset for presentation at the North American Neuromodulation Society (NANS) meeting in January 2023 and publish as soon as possible thereafter.