Nevro’s Senza SCS Label Expanded to Non-Surgical Refractory Back Pain

Chronic pain treatment company Nevro gained FDA approval expanding its Senza spinal cord stimulation (SCS) system’s label to treat non-surgical refractory back pain (NSRBP). The approval specifically covers the company’s 10kHz therapy and makes it the only SCS system with a specific indication for NSRBP.
 
“Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery,” Nevro Chairman, CEO, and president D. Keith Grossman told the press. “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.”
 
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.”
 
12-month SENZA-NSRBP trial results were presented at the North American Neuromodulation Society (NANS) Annual meeting this year. Study participants reported “profound improvements” in pain relief, function, quality of life, awareness of positive change, and daily opioid use reduction compared to conventional medical management a year post-implant.
 
Study participants will continue to be followed to 24 months.
 
Reference
¹ Kapural, Jameson, Johnson, et al. Twelve-month Outcomes from RCT: 10kHz Spinal Cord Stimulation for Treating Non-Surgical Refractory Back Pain. Presented at North American Neuromodulation Society (NANS); January 13-15, 2022; Orlando, FL.