Mainstay Medical recently announced the publication of three-year clinical data from the post-market clinical follow-up (PMCF) study of 33 ReActiv8 patients at five medical centres across the UK. ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction via restorative neurostimulation.
The three-year results, published in the British Journal of Pain, demonstrate that a substantial portion of patients experienced statistically significant improvements in measures of pain (numerical rating scale [NRS]), disability (Oswestry disability index [ODI]) and quality of life (EQ-5D-5L).
These results indicate that the response to ReActiv8 for these patients is durable and improves over time, validating ReActiv8’s restorative mechanism of action, a Mainstay press release notes. In addition, these real-world outcomes are consistent with three-year data from 133 patients in the pivotal ReActiv8-B clinical trial, which were announced in September 2022.
Notable outcome measures include CLBP remission (visual analogue scale [VAS] ≤2.5/NRS ≤3), which 64% of patients experienced in ReActiv8-B and 70% of patients experienced in the PMCF study. In addition, ≥50% reduction in low back pain was seen in 77% in ReActiv8-B versus 67% in PMCF; ≥15-point reduction in ODI was observed in 71% in ReActiv8-B and 55% in PMCF; and improvements of ≥50% in VAS/NRS and/or ≥20 points in ODI were reported as 79% in ReActiv8-B compared to 75% in PMCF.
Simon Thomson (Mid and South Essex University Hospitals, Essex, UK), corresponding author of the PMCF study, said: “These results demonstrate durability and safety of this therapy in chronic back pain sufferers who would have continued to be crippled and dominated by their symptoms but for ReActiv8. These patients, drawn from usual UK pain clinics, are now as good as those seen in the continuation cohort from the more highly selected, randomised ReActiv8-B trial.”
Jason Hannon, CEO of Mainstay, added: “We are pleased to add these compelling results to the growing global body of positive peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes to this severely affected patient population. Most importantly, the continued improvement in patient outcomes observed in the real-world setting is consistent with the results from our controlled clinical trials.”