Becker's ASC Review

See the study results at ParadigmSpine.com or CoflexSolution.com Level 1 Evidence is Adding Up. coflex ® Interlaminar Stabilization ® is the the first and only device indicated for lumbar spinal stenosis that has produced Level 1 Evidence in two different randomized studies against two different control groups in two different countries. The recent ESCADA publication° shows statistical superiority in Composite Clinical Success † for coflex ® compared to decompression alone. (p=0.017) coflex ® : a proven option for treating lumbar spinal stenosis that can be used in any setting of care, including your ASC. ° European Study of Coflex and Decompression Alone. Prospective, Randomized, Controlled, Multicenter Study With Two-year Follow-up to Compare the Performance of Decompression With and Without Interlaminar Stabilization; Joerg Franke, MD, PhD, Michael Rauschmann, MD, Dieter Adelt, MD, Sven Schmidt, MD, Matteo Bonsanto, MD, Steffen Sola, MD. Journal of Neurosurgery: Spine. EPub ahead of Print, Jan 26, 2018 † Composite Clinical Success (CCS). Overall trial success was based on a composite endpoint; a combined outcome measure in which all four components must be met: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions or lumbar injections; 3) neurologic maintenance or improvement without worsening; 4) no device-related severe adverse events. coflex ® and Interlaminar Stabilization ® are registered trademarks of Paradigm Spine, LLC. Key Findings at 24 Months: • coflex patients experienced significant improvement in walking distance from baseline (p<0.001) • the coflex group demonstrated statistical superiority for foraminal and posterior disc height maintenance compared to decompression alone (p<0.001) • the decompression alone group had a 1.75x higher risk for secondary intervention compared to the coflex group (p=0.055) • the decompression alone group experienced 228% more lumbar injections than the coflex group (p=0.0065)

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