Nevro Corporation has announced that data from the SENZA painful diabetic neuropathy (PDN) randomised controlled trial (RCT)—which the company says is the largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN—will be presented at the American Diabetes Association (ADA) 82nd Scientific Sessions (3–7 June 2022, New Orleans, USA). Nevro will also showcase its HFX platform of SCS solutions at its exhibit booth.
During a poster presentation, Erika Petersen (University of Arkansas for Medical Sciences, Little Rock, USA) will present 24-month follow-up results from the original 10kHz arm of the SENZA-PDN RCT. The objective of this study was to compare Nevro’s proprietary, high-frequency (10kHz) SCS, plus conventional medical management (CMM), to CMM alone in 216 patients across 18 US centres.
Complete 12-month results, published in Diabetes Care, demonstrated significantly improved and sustained outcomes with 10kHz therapy, including substantial, sustained pain relief and improved health-related quality of life in patients suffering from PDN, Nevro claims in a press release.
In addition, Petersen will be joined by George Grunberger (Wayne State University School of Medicine, Detroit, USA) at ADA 2022 for a product theatre presentation entitled: “Revolutionizing the Treatment of Painful Diabetic Neuropathy with High Frequency (10kHz) Spinal Cord Stimulation”.
Nevro expects complete 24-month data from the SENZA-PDN RCT to be available in the fourth quarter of 2022 and plans to submit this dataset for presentation at the North American Neuromodulation Society (NANS) meeting in January 2023—and publish as soon as possible thereafter, according to the release.