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Spineology U.S. Fusion Trial 24-Month Outcomes Data -

Two-year outcomes from Spineology's SCOUT trial of the OptiMesh® device revealed substantial improvements in low back pain and function scores at 6, 12 and 24 months. SCOUT (Spineology Clinical Outcomes Trial) is a 102-subject prospective, multi-center, non-randomized performance goal investigation designed to evaluating safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures to treat degenerative disc disease. Eighty-two patients have completed 24-month follow-up, to date, showing a 98% fusion rate and 90% of subjects reporting “Excellent” or “Good” satisfaction. The original 2003 FDA 510(k) clearance for OptiMesh supported graft containment inside the vertebral body. Data from SCOUT will support the submission of a De Novo application to FDA for expanded indications, allowing use with bone graft and supplemental posterior fixation in lumbar interbody fusion.