High-frequency SCS demonstrates ‘substantial improvement’ in health-related quality of life outcomes

Nevro Corporation announced that the full 12-month results of the SENZA-PDN randomized controlled trial (RCT), including health-related quality of life outcomes in patients with painful diabetic neuropathy (PDN) treated with 10 kHz high frequency spinal cord stimulation (SCS), have been published in Mayo Clinic Proceedings: Innovations, Quality, and Results.

“In addition to the strong clinical efficacy of HFX therapy that has already been demonstrated in our landmark SENZA-PDN trial, these results demonstrate improvement in several important health-related quality of life parameters in patients with PDN,” said Dr. 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, this 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 data published in Mayo Clinic Proceedings showed that treatment with 10 kHz therapy resulted in significant pain relief and multiple significantly improved measures of health-related quality of life, according to a press release. Results included significantly less interference of pain with sleep, mood, and daily activities.

And, at 12 months, 10 kHz SCS treatment resulted in an improvement in overall health-related quality of life that was 2.5 to 4.5 times greater than the minimally clinically important difference. Additionally, more than 70% of clinicians and patients reported better or much better overall improvement than pre-SCS baseline.

These results lasted over 12 months and support SCS treatment at 10 kHz in patients with refractory PDN, the statement adds. Additionally, approximately 92% of participants were satisfied or very satisfied with the 10 kHz therapy.

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