Nevro Corporation has announced that the complete 12-month results from the SENZA-PDN randomised controlled trial (RCT), including health-related quality of life outcomes in patients with painful diabetic neuropathy (PDN) treated with high-frequency 10kHz spinal cord stimulation (SCS), have been 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.”
The published data in Mayo Clinic Proceedings showed treatment with 10kHz therapy resulted in significant pain relief and multiple significantly improved metrics of health-related quality of life, according to a press release. Results included significantly less pain interference with sleep, mood and daily activities.
And, at 12 months, 10kHz SCS treatment resulted in improvement in overall health-related quality of life that was 2.5- to 4.5-fold higher than the minimally clinically important difference. Furthermore, more than 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 10kHz SCS treatment in patients with refractory PDN, the release adds. In addition, approximately 92% of participants were satisfied or very satisfied with 10kHz therapy.