Treat The Cause, Not Just the Symptoms for Mechanical CLBP
The Only FDA-Approved Restorative Treatment Option for Patients with Mechanical Chronic Low Back Pain
Discover the science behind and significance of the Multifidus Muscle and Neuromuscular Control in managing chronic lower back pain of mechanical origin.
Fundamentals of ReActiv8 Course: Learn about the pathology, the solution, and identifying candidates for ReActiv8
Restorative Neurostimulation.
Compelling Clinical Data:
Latest Collection of clinical evidence supporting ReActiv8 Restorative Neurostimulation
- 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.
- 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
Real World Evidence
- 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
- 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
Society Support for ReActiv8 Restorative Neurostimulation
- 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
Commercial Insurance Approval for ReActiv8 Restorative Neurostimulation
