Basis for the approval was the SENZA-PDN randomized controlled trial, which showed the system’s ability to substantially sustain pain relief and improve health-related quality of life.
The FDA has approved Nevro’s unique 10 kHz stimulation Senza System to treat patients with chronic pain associated with painful diabetic neuropathy (PDN), becoming the only spinal cord stimulation (SCS) system approved by the FDA with a specific indication to treat PDN.
Nervo will immediately initiate commercial launch activities in the US under its recently launched HFX branding, as HFX for PDN. Additionally, it will be executing phased launch plans in the UK, Germany and Australia, with further expansion planned in 2022.
"This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options,” Keith Grossman, chief executive officer and president, Nervo, said in a statement. "We are thrilled that we can now begin commercial launch activities in the U.S. and believe this new indication will be an important driver of the long-term growth of our business for years to come."
The basis for the approval came from the SENZA-PDN randomized controlled trial (NCT03228420), which had full results published in April 2021. The data from the study showed that the SCS system substantially improved pain relief and health-related quality of life over 6 months in patients with refractory PDN.
Lead investigator Erika Peterson, MD, FAAS, professor of neurosurgery, and director, Functional and Restorative Neurosurvery, 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. Percentage of participants with 50% or more pain relief on visual analogues scale (VAS) without worsening of baseline neurological deficits at 3 months was the prespecified primary end point.
In total, 79% (75 of 95) of patients in the 10-kHz SCS plus CMM group met the primary end point compared to just 5% (5 of 94) of patients in the CMM group (difference, 73.6% [95% CI, 64.2-83.0]; P <.001). At 6 months, the average pain relief in the Senza SCS treatment arm was 76% as compared to an average worsening of 2% in the control arm.
"The substantial pain relief and improved quality of life demonstrates that 10 kHz therapy can safely and effectively treat this patient population,” Peterson said in a statement. "I'm grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients."
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 in 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). Additionally, 92% of patients who received the 10 kHz SCS therapy reported either “satisfied” or “very satisfied” at the 6-month mark, compared to 91% of patients in the CMM group who were either “dissatisfied” or “very dissatisfied” with treatment.
"Diabetic neuropathy is one of the most prevalent and debilitating, chronic complication of diabetes, and for years, PDN patients have struggled with a lack of effective treatment options when conventional medications fail or are not tolerated,” Frances Broyles, MD, medical director, Diabetes/Endocrinology and Nutrition, Swedish Health Services, said in a statement. "The ability to now offer Nevro's proven 10 kHz Therapy, which may enable discontinuation of long-term drug therapy and eliminate unwanted drug side effects, is a welcome addition as a treatment option for my PDN patients dealing with this challenging condition. My personal practice experience with the Nevro 10 kHz Therapy was nothing short of life changing for the patient.”