Nevro (NYSE:NVRO) today reported positive 12-month data from the Senza-NSRBP randomized controlled trial of its implantable neurostimulation device for back pain.
Redwood City, California–based Nevro’s data, published in Journal of Neurosurgery: Spine, showed that high-frequency 10 kHz spinal cord stimulation (SCS) therapy results in profound improvement in non-surgical refractory back pain (NSRBP) patients in comparison to conventional medical management (CMM).
Outcomes from 121 patients implanted with 10 kHz SCS, including those who crossed over from the CMM arm to 10 kHz therapy, displayed benefits such as 78.2% of participants reporting pain relief, with the average pain relief registering at 72.1% (70.4% in the crossover arm).
The study demonstrated adverse event report rates similar to what has been reported before, including the Senza-RCT, with only three of 145 permanent SCS devices explanted (all due to wound complications) for an explant rate of 2.1%. There were no explants due to loss of efficacy.
Nevro also reported functional improvement that included 75% of subjects receiving 10 kHz therapy having clinically significant improvement in scores on the Oswestry Disability Index (ODI). In addition, despite no specified opioid weaning protocol, usage in the study declined significantly by 46% on average in subjects receiving treatment at six and 12 months, according to a news release.
“We are thrilled that our 12-month NSRBP trial results clearly demonstrate the durable pain relief that can be achieved with 10 kHz therapy,” Nevro Chairman, CEO and President D. Keith Grossman said in the release. “We look forward to expanding access to high-frequency SCS therapy by providing the needed evidence of clinical benefit and reduced health care utilization when 10 kHz Therapy is used to treat refractory back pain in patients who have not had previous spine surgery.
“No other SCS treatment has demonstrated such positive results in treating NSRBP patients, and we look forward to using this data to support increased patient access and improve market awareness and penetration.”