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Home » FDA approves expanded labeling for Nevro spinal cord stimulation

FDA approves expanded labeling for Nevro spinal cord stimulation

January 19, 2022 By Danielle Kirsh

NevroNevro (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.

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well, Pain Management, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Nevro Corp.

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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