Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system for the treatment of chronic pain associated with painful diabetic neuropathy (PDN). According to a Nevro press release, this approval is specific to the US medical device company’s 10kHz stimulation—making it the only spinal cord stimulation (SCS) system approved by the FDA with a specific indication to treat PDN.
The company will immediately initiate commercial launch activities in the USA under its recently launched HFX branding, as HFX for PDN. In the SENZA-PDN randomised controlled trial, which assessed Nevro’s technology as a treatment option for PDN, study participants demonstrated “significantly improved and sustained outcomes” with 10kHz SCS including substantial, sustained pain relief and improved health-related quality of life.
The six-month results for the trial were previously published in JAMA Neurology in April 2021, and the 12-month follow-up results and six-month crossover patient data were recently presented at the American Diabetes Association 81st Scientific Sessions (ADA; 25–29 June 2021, virtual).
“The substantial pain relief and improved quality of life demonstrates that 10kHz therapy can safely and effectively treat this patient population,” stated Erika Petersen, professor of Neurosurgery and director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences (Little Rock, USA), and lead investigator of the SENZA-PDN study. “I am grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have a far-reaching impact on the lives of PDN patients.”
Data from the trial will be used to support physician referral decisions as well as market access initiatives to expand payer coverage of this procedure, according to a Nevro press release. The company plans to publish these 12-month results, including the six-month crossover patient data, in a peer-reviewed journal. Study participants will also continue to be followed out to 24 months.
“Diabetic neuropathy is one of the most prevalent and debilitating, chronic complications of diabetes, and, for years, PDN patients have struggled with a lack of effective treatment options when conventional medications fail or are not tolerated,” said Frances Broyles, medical director of Diabetes/Endocrinology and Nutrition at Swedish Health Services (Seattle, USA).
“The ability to now offer Nevro’s proven 10kHz 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 10kHz therapy was nothing short of life-changing for the patient.”