Nevro Shares 12-Month SENZA-NSRBP Trial Results

Nevro today released 12-month data from its SENZA-NSRBP randomized controlled trial of 121 non-surgical refractory back pain (NSRBP) patients implanted with 10 kHz spinal cord stimulation (SCS) devices. Results were published in Journal of Neurosurgery: Spine showing high-frequency SCS profoundly improves NSRBP compared to conventional therapies.
 
At 12 months, 78.2 percent of the patients in the 10 kHZ SCS study arm reported pain relief >50 percent from baseline, with average pain relief of 72.1 percent. At six months, about 78.2 percent of participants reported >50 percent from baseline with average relief of 70.4 percent.
 
Only three SCS implants were removed, all due to wound complications.
 
“There is a significant unmet need for safe and effective, non-pharmacologic therapy for NSRBP, as currently there are few effective treatment options,”, Lead SENZA-NSRBP study investigator and Carolina’s Pain Institute Dr. Leonardo Kapural told the press. “This study provides high level clinical evidence and confidence to the neurosurgery community regarding a therapeutic option for intractable back pain when a patient is not a candidate for spine surgery.  All patients in this trial had tried and failed conventional medical management for an average duration of eight years, and experienced profound improvements in pain, disability and quality of life with 10 kHz SCS at 12 months post-implant.”
 
Average Oswestry Disability Index (OSI) score for each participant at baseline indicated sever disability. Post-implant, scores grew to borderline minimum/moderate disability—an average 20-point reduction.
 
Opioid usage also reduced by 46 percent at six and twelve months on average despite no specified opioid meaning protocol.
 
“We are thrilled that our 12-month NSRBP trial results clearly demonstrate the durable pain relief that can be achieved with 10 kHz Therapy,” said Nevro Chairman, CEO, and president D. Keith Grossman. “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.”
 
Data from this trial was the basis of the company’s recent FDA approval for NSRBP.