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Nevro gets FDA nod for expanded labeling of SCS system for back pain
Nevro (NYSE:NVRO) received FDA approval for expanded labeling for its Senza Spinal Cord Stimulation (SCS) system to treat Non-Surgical Refractory Back Pain
(NSRBP).
The company said the 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.
The company noted that the SENZA-NSRBP study participants receiving 10 kHz Therapy showed 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.
Nevro (NYSE:NVRO) received FDA approval for expanded labeling for its Senza Spinal Cord Stimulation (SCS) system to treat Non-Surgical Refractory Back Pain
(NSRBP).
The company said the 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.
The company noted that the SENZA-NSRBP study participants receiving 10 kHz Therapy showed 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.