Clinical Research

Baxano, Inc. is dedicated to the development, implementation and reporting of various clinical research activities.

All devices marketed by Baxano Inc. have received clearance from the U.S. Food and Drug Administration.  Further clinical and economic support for the iO-Flex® System includes:

• Pre-clinical validation of the Neuro Check® device
• Cadaver CT analysis comparing the iO-Flex® System and standard microdecompression
• Completed prospective and retrospective U.S. clinical studies of the iO-Flex® System in patients with lumbar spinal stenosis         
• The iO-Flex® study, a post-market prospective single arm study evaluating reduction in pain and symptom severity in patients with 1-2 level lumbar spinal stenosis  (Enrollment complete)
• The STRiDE study, a post-market prospective study evaluating the iO-Flex® System in treating patients with spinal stenosis and stable grade I degenerative spondylolisthesis