FDA approve Coflex (Paradigm Spinal) to treat moderate to severe Stenosis

The FDA has granted a Premarket Approval Order for Coflex, a motion preserving interlaminar stabilization device from Paradigm Spine, for the treatment of moderate To severe Stenosis with or without back pain. The approval is based on comprehensive Level 1 comparative effectiveness study for the treatment of spinal Stenosis. The six year clinical trial demonstrates Coflex provides better or equivalent outcomes in all major primary and secondary clinical and radiologic assessments, while maintaining natural motion at both treated and adjacent spinal levels. The study results are based on data evaluated from 322 patients, at 21 sites throughout the United States, who presented with a history of spinal stenosis that failed over 6 months of conservative therapy. The FDA approval concludes that Coflex represents a reasonable alternative to posterolateral fusion for the treatment of spinal stenosis. Coflex is already CE marked in the EU.