Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced receipt of FDA approval for expanded labeling for its Senza® Spinal Cord Stimulation (SCS) System for the treatment of Non-Surgical Refractory Back Pain (NSRBP). This approval is specific to Nevro’s proprietary 10 kHz Therapy and differentiates Nevro’s Senza System as the only SCS system with specific labeling to treat NSRBP patients.
“Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery,” said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. “This FDA approval marks another milestone in Nevro’s commitment to expanding access to 10 kHz Therapy for these underserved patients. Nevro is now the only SCS company with specific, on-label indications for treating both NSRBP and Painful Diabetic Neuropathy patients.”
Mr. Grossman continued, “We would like to thank our lead Principal Investigator team, Dr. Leonardo Kapural, Dr. Jessica Jameson and Dr. Naresh Patel, as well as the rest of our clinical trial investigators and their patients for their study participation and ongoing partnership, without whom this approval would not have been possible.”
The 12-month results for the SENZA-NSRBP RCT were recently presented at the North American Neuromodulation Society (NANS) 25th Annual Meeting on January 15, 2022. SENZA-NSRBP study participants receiving 10 kHz Therapy demonstrated profound improvements in pain relief, function, quality of life, awareness of positive change and reduction in daily opioid use versus Conventional Medical Management (CMM) at 12-months post-implant. Results also included comparable improvements for patients that crossed over from CMM to 10 kHz after six months.
These data will be used to support continued market penetration and market access initiatives to further expand payer coverage of this procedure. The company plans to publish these 12-month results, including the six-month crossover patient data, in a peer-reviewed journal. Study participants will continue to be followed out to 24 months.
Nevro’s SENZA-NSRBP study, the largest RCT of spinal cord stimulation treatment conducted for non-surgical refractory back pain (NSRBP), compares 10 kHz SCS plus CMM to CMM alone in 159 randomized patients at 15 centers in the United States. Each randomized patient underwent a consultation with a spine surgeon where they were deemed to not be an appropriate candidate for spine surgery. The primary endpoint of the study was a responder rate (≥50% pain relief) at three-month follow-up. The study included an optional cross-over at six months and participants will continue to be followed out to 24 months.
Source: Company Press Release
