Summary

• 204 participants implanted with ReActiv8 system
• Randomized, sham-controlled, double-blinded
• Completer analysis on 62% patient at 5 years (n=126)
• Intent-to-Treat analysis accounting for 100% patients (n=204) provided with Mixed Model of Repeated Measures imputation
• Explants for success demonstrate increasing number of patients no longer need treatment to maintain clinical benefit
• ONLY restorative therapy for patients suffering from non-surgical mechanical CLBP evidenced by multifidus dysfunction

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Summary

• Data from 261 patients completing 2 year follow up from 3 clinical studies (ReActiv8-B, ReActiv8-C, and PMCF)
• Combination of RCT data and Real World Evidence
• Four equal sized cohorts analyzed based on age range (n=65)
• Statistically significant improvements in disability (ODI) and quality of life (EQ-5D-5L) were seen at all assessment time points compared to baseline.
• Consistent improvements in pain (VAS/NRS) at all time points compared to baseline.
• Patients derived significant and clinically meaningful benefit in disability, health related quality of life, and pain, irrespective of age.

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Summary

• 77% of participants had ≥50% VAS reduction
• 67% reported CLBP resolution (VAS ≤ 2.5 cm)
• 63% had a reduction in ODI of ≥20 points
• Trajectory and durability of three year clinical benefits are consistent with restoration of neuromuscular control and muscle rehabilitation.

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Summary

• 72% of participants had ≥50% pain relief
• 67% reported CLBP resolution (VAS ≤ 2.5 cm)
• 62% had a reduction in ODI of ≥20 points
• Two-year results show durable, statistically significant, and clinically substantial benefits in patients with severe, disabling CLBP and multifidus muscle dysfunction

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Summary

• 57% of patients experienced a substantial improvements of ≥ 50% reduction in NRS pain score
• 51% of patients experienced a substantial improvement of ≥ 15-point reduction in ODI score
• Excellent safety profile compared to similarly implanted devices

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Summary

• Single surgeon, single center, real world evidence with one-year clinical follow-up
• 44 patients from the Reactiv8-C study were consecutively included into this cohort if they presented with back pain (NRS) ≥ 6 and no prior lumbar surgery
• 40 patients completed all required testing at the follow up visit showing statistically significant improvements in pain (NRS), disability (ODI) and quality of life (EQ-6D-5L)
• Response to ReActiv8 is durable and benefits accumulate over time consistent with the restorative mechanism of action
• No lead migrations
• Results of this real-world experience are consistent with the published data from the earlier ReActiv8-A and ReActiv8-B studies

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More Information

• Full length presentation of “The Role Muscles in Chronic Low Back Pain: The relationship between multifidus dysfunction and restoration” and “5-Year Outcomes with Restorative Neurostimulation: Understanding the Mechanism of Action & Avoiding Palliative Treatments” with all presenters.

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Summary

• The highest-level trial of the permanently implanted PNS system was international, multi-center, prospective, randomized, active, sham controlled, blinded trial, which generated high, level I-A evidence supporting the significance of the treatment effect
• The ReActiv8-B trial “demonstrated clinical effectiveness as measured by substantial and durable improvements in pain, disability, and quality of life in a cohort of patients with a favorable benefit risk profile
• The rates of adverse events are consistent with known SAE rates for spinal cord stimulation therapy; however there was no finding of lead migration
• The ASPN Back Group recommends offering the permanently implanted PNS system given that there is a high certainty that the net benefit is substantial

Summary

• Restorative neurostimulation for CLBP is supported by several clinical studies that show robust and durable clinical effects over the pretreatment condition.
• The totality of evidence suggests that in a well-selected patient population who have exhausted conventional care paradigms, the potential benefits outweigh the risks and costs.
• These patients tend to be exposed to multiple therapies with limited durability, resulting in a continuous cycle of high-cost health care utilization.
• Restorative neurostimulation should be considered for clinically appropriate patients who have exhausted reasonable conservative approaches.