Nevro (NYSE:NVRO) today said it received FDA approval for expanded labeling of its Senza spinal cord stimulations system to treat non-surgical refractory back pain (NSRBP).
Redwood City, California–based Nevro designed the 10 kHz therapy to improve pain relief and reduce opioid use. The 12-month results from a study of the system showed that patients who received the therapy demonstrated “profound” improvements in pain relief, function, quality of life, awareness of positive change and reduction in daily opioid use compared to conventional medical management at 12-months post-implant, according to the company.
“Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery,” CEO and president Keith Grossman said in a news release. “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.”
The data from the study will be used to support continued market entry and access initiatives to expand payer coverage of this procedure. Nevro plans to publish the 12-month results and six-month crossover patient data in a peer-reviewed journal. Patients on the study will continue to be followed out to 24 months.