S11| Volume 24, SUPPLEMENT 1, S2-S3, November 2021

Long-Term Durability of Restorative Neurostimulation for Chronic Mechanical Low Back Pain – Two-Year Pivotal Trial Results

      Introduction: Chronic mechanical low back pain (CMLBP) can be caused by impaired neuromuscular control and degeneration of the multifidus muscles resulting in functional instability of the lumbar spine. Available treatment options often lack long-term effectiveness and prognosis is unfavourable. An implantable Restorative Neurostimulation system (ReActiv8® by Mainstay Medical), that stimulates the L2 medial branches of the dorsal rami to reactivate neuromuscular control, received FDA Premarket Approval based on evidence from the ReActiv8-B pivotal trial ( Here we report the two-year results of the open-label phase of this trial.
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