At 6 months, 62% of the 10 kHz spinal cord stimulation treatment group had observed improvement upon investigator-assessed neurological examination, compared to 3% of conventional medical management subjects.
Recently published data from the prospective, open-label SENZA-PDN trial (NCT03228420) demonstrated that treatment with the Senza System, Nevro’s 10-kHz spinal cord stimulation (SCS) system, substantially improved pain relief and health-related quality of life over 6 months in patients with refractory painful diabetic neuropathy (PDN).1,2
Results from this trial provide the basis for the company’s recent premarket approval (PMA) supplement submission to the FDA. If cleared, the Senza System would be the only SCS system FDA-approved with a specific on-label indication for treating PDN.
Lead investigator Erika Peterson, MD, FAANS, professor of neurosurgery, Director, Functional and Restorative Neurosurgery, University of Arkansas for Medical Sciences, and colleagues compared the efficacy and safety of the Senza System to conventional medical management (CMM) in 216 randomized patients. The prespecified primary end point was percentage of participants with 50% or more pain relief on visual analogue scale (VAS) without worsening of baseline neurological deficits at 3 months.
In total, 75 of 95 patients (79%) in the 10-kHz SCS plus CMM group met the primary end point compared to just 5 of 94 patients (5%) in the CMM group (difference, 73.6% [95% CI, 64.2-83.0]; P <.001).2
"It’s been an honor to lead this clinical study showing the significant benefit of 10 kHz spinal cord stimulation for PDN patients who have suffered for years with refractory symptoms,” Peterson said in a statement.1 “The substantial pain relief and improved quality of life sustained over 6 months demonstrates that this therapy can safely and effectively treat this patient population. I’m grateful to my co-investigators and the patients who participated in this study, as the results will have far-reaching impact on the lives of PDN patients.”
At 6 months, the average pain relief in the 10 kHz SCS treatment arm was 76% as compared to an average worsening of 2% in the control arm. For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months compared to mean pain VAS scores of 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months in the 10-kHz SCS plus CMM group.
There were no study-related adverse events (AEs) reported for the CMM group while there were 18 reported AEs among 14 patients in the 10-kHz SCS plus CMM group. Only 2 of 90 permanent SCS devices were explanted at 6 months for a 2.2% explant rate (both explants were due to infection).
Investigators also assessed meaningful worsening or improvement in motor, sensory, or reflex testing. Improvement from baseline without any worsening on examination was documented in 6 patients in the CMM group (6%) and 63 in the 10-kHz SCS plus CMM group (72%) at 3 months (difference, 66% [95% CI, 55.4-76.6]; P <.001) and 3 patients in the CMM group (3%) and 52 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6% [95% CI, 47.6-69.6]; P <.001).
At 6 months, 92% of patients who received the 10 kHz SCS therapy were either “satisfied” or “very satisfied” compared to 91% of patients in the CMM group who were either “dissatisfied” or “very dissatisfied” with treatment.
"No conventional, low-frequency SCS treatments have been thoroughly evaluated or demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to offer our innovative treatment option to patients who are unable to find relief with currently available pharmacologic options," Keith Grossman, chairman, chief executive officer and president, Nervo, said in a statement.1 “A 6-month review cycle by the FDA could position the company to achieve approval and initiate US launch activities to provide HF10® therapy for the treatment of chronic pain in PDN patients during the second half of 2021."