Superion® Clinical Study

Vertiflex® has compiled the largest, most rigorous body of device clinical evidence related to relieving the pain of moderate lumbar spinal stenosis (LSS). 470 patients were enrolled in a Superion U.S. IDE trial at 29 sites with a 24-month follow-up and annually thereafter through 60 months. The data suggest significant relief from the symptoms of spinal stenosis is achievable, along with very high patient satisfaction with the surgery.


http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140004b.pdf