VertiFlex announced it has submitted the final module of the pre-market approval application to the U.S. Food and Drug Administration to support approval of the Superion Interspinous Spacer System.
The final module covers the clinical results from the Superion IDE trial, which involved the enrollment of 470 patients between June 2008 and December 2012 at 31 centers across the United States. The trial evaluated the safety and effectiveness of the Superion system for the treatment of lumbar spinal stenosis.
VertiFlex is a developer of advanced minimally invasive spinal surgery technologies.
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