Ortho device panel preview
This article was originally published in The Gray Sheet
Executive Summary
FDA's Orthopaedic Rehabilitation Devices Panel will convene Aug. 31 to review St. Francis Medical's PMA for the X-Stop interspinous process distraction system for non-fusion treatment of lumbar spinal stenosis, a degenerative disorder causing reduced mobility and pain usually treated with spinal fusion. The PMA is based on a 200-patient randomized trial comparing X-Stop to non-operative therapy. In the study, efficacy is measured as improvement in pain symptoms and increase in physical function and mobility...