Compelling Clinical Data
Collection of clinical evidence and scientific literature supporting ReActiv8 Restorative Neurostimulation
Learn about ReActiv8 in motivated elderly patients
ReActiv8 – B Trial for FDA Approval
- 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
Mechanism of Action / Understanding the problem
Understanding loss of neuromuscular control
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Publications on multifidus dysfunction
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Mechanism animation
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Hear from your peers: Videos of KOLs discussing problem
- 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
Hear from the patients: Highlights from Pt testimonials talking about instability / clinical cues
- 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
Clinical outcomes
Peer reviewed publications
- 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
ReActiv8-B publications
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
ReActiv8-A publications
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
PMCF publications
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Abstracts
Hear from your peers: KOL videos presenting or discussing impact of data
- 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
Hear from the patients: Highlights from Pt testimonials talking about impact of therapy on function, pain, quality of life
- 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
Patient Identification
Patient ID 1-pager
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
KOL videos discussing patient presentation and clinical cues
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
Videos of physical assessments of LM dysfunction
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
Link to background literature on PIT / MLT / AM
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
MRI interpretation
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
More than just the video – need rule in and rule out
- 57% of patients experienced a substantial improvement 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-5D-5L)
- Response to ReActiv8 is durable and the 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
Hear from your peers: KOL videos discussing pt work-up
- 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
Hear from the patients: Highlights from Pt testimonials talking about impact of therapy on function, pain, quality of life
- 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
ReActiv8
Hear from the patientLinks to relevant labeling, approvals, regulatory sites etcs: Highlights from Pt testimonials talking about impact of therapy on function, pain, quality of life
- Re-establishing control of the multifidus muscle may not be feasible with physical therapy and exercise alone.
- Direct electrical stimulation of the multifidus may be a suitable alternative for motor dysfunction.
- A combination of history, imaging, and multiple provocative maneuvers has allowed for increased accuracy in diagnosis, leading to excellent outcomes.
- Clinical instability is related to chronic low back pain.
- Altered motor control and inhibition of the multifidus is a cause of clinical instability and CLBP.
- Back pain due to disrupted muscle control is associated with neuroplastic changes in the motor cortex, which can be reversed with elimination of back pain.
- A program of biofeedback guided motor control exercise of the multifidus can restore some disrupted motor control, but traditional physiotherapy may be very difficult in the context of inhibition.
Implant animation
- Re-establishing control of the multifidus muscle may not be feasible with physical therapy and exercise alone.
- Direct electrical stimulation of the multifidus may be a suitable alternative for motor dysfunction.
- A combination of history, imaging, and multiple provocative maneuvers has allowed for increased accuracy in diagnosis, leading to excellent outcomes.
- Clinical instability is related to chronic low back pain.
- Altered motor control and inhibition of the multifidus is a cause of clinical instability and CLBP.
- Back pain due to disrupted muscle control is associated with neuroplastic changes in the motor cortex, which can be reversed with elimination of back pain.
- A program of biofeedback guided motor control exercise of the multifidus can restore some disrupted motor control, but traditional physiotherapy may be very difficult in the context of inhibition.
Hear from your peers: KOL videos discussing system implant and patient follow-up
- 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
Hear from your peers: KOL viHear from the patients: Highlights from Pt testimonials talking incorporating ReActiv8 into their livesdeos discussing system implant and patient follow-up
- 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
Special Topics
Learn about ReActiv8 in motivated elderly patients
Publications
- Observation of trunk movement is considered an important part of the clinical examination of patients with low back pain (LBP).
- The presence of forward-bending movement aberrance is frequently seen in patients with acute/subacute, nonspecific LBP, compared to those without a history of LBP.
- Aberrant movements indicate that some motor control or musculoskeletal impairment remains unresolved in this group.
- The lumbar multifidus muscle is a critical contributor to lumbar spine stability and deficits in its function are associated with LBP.
- A physical examination method assessing multifidus function could provide great clinical utility as a diagnostic approach.
- Results provide evidence supporting the reliability and validity of the Multifidus Lift Test (MLT) to assess lumbar multifidus function.
Available references on specific challenges or opportunities
- Clinical or functional instability consists of insufficient motor control and is a factor in abnormal inter-segmental movement and LBP, where no lumbar architecture defect can be observed on imaging.
- In the absence of imaging as a tool, reliable physical assessments are critical for proper diagnosis of functional instability.
- The prone instability test (PIT) demonstrates good reliability and moderate accuracy in diagnosing functional lumbar instability.
Hear from your peers: Videos of KOLs discussing this population
- 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
Hear from the patients: Highlights from Pt testimonials from this population
- 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
Learn about ReActiv8 in patients with stable grade 1 spondylolisthesis
Publications
- The Multifidus morphology is uniquely different from other lumbar muscles, and therefore has a special role in lumbar stability.
- Changes in the multifidus have been found by many studies to be related to low back pain.
- Injury and overloading of lumbar tissues has been shown to cause multifidus inhibition.
- Clinical studies have demonstrated that the multifidus can be rehabilitated and low back pain decreased.
- Lumbar multifidus atrophy is related to low back pain.
- Multifidus atrophy can be observed and categorized via MRI as fatty infiltration of the muscle.
- Multifidus fatty infiltration has been strongly associated with low back pain.
Available references on specific challenges or opportunities
- The spinal stabilizing system consists of three subsystems:
- the passive spinal column subsystem,
- the active muscular subsystem,
- the neural and feedback control subsystem.
- Injury, degeneration or disease can cause dysfunction in the spinal system, which cannot be compensated for beyond certain limits.
- The neutral zone is the spinal range of motion where there is little to no resistance.
- An increase in the size of the neutral zone is correlated with spinal degeneration and injury.
- The bodies’ inability to maintain neutral zones within physiological limits, therefore causing mechanical dysfunction and pain, is termed “clinical instability”.
- Improved neurocontrol and motor function may reduce an aberrant neutral zone, decreasing clinical instability and reducing pain.
Hear from your peers: Videos of KOLs discussing this population
- 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
Hear from the patients: Highlights from Pt testimonials from this population
- 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
Learn about ReActiv8 in patients post RFA
Publications
- Increased neutral zones as a result of injury or degeneration are shown to be correlated to pain.
- The spinal muscles provide significant stability to the spine.
- Less efficient muscular control and decreased stability has been found in patients with low back pain.
- A compromised spinal system can be stabilized with muscle strengthening and retraining of the neuromuscular control system.
- Inhibition produces underlying weakness in muscles associated with joint disease, and studies suggest possible neurophysiological mechanisms are involved.
- Severe motor inhibition limits the potential response to voluntary therapeutic exercise.
- Studies of intermittent neurostimulation of motor neurons in patients showed no evidence of the atrophy in type I and type II muscle fibers seen in untreated patients.
Available references on specific challenges or opportunities
Society Guidelines and Support
- The highest-level trial of the permanently implanted PNS system was an 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 high certainty that the net benefit is substantial.
Hear from your peers: Videos of KOLs discussing this population
- 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
Hear from the patients: Highlights from Pt testimonials from this population
- 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
