The STEPS - Totalis™ Trial

Inclusion Criteria: * Male or female subjects greater than or equal to 55 years of age * Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion * VAS leg symptom severity \>50 (in either leg) during episodes of neurogenic claudication * Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms * Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence * Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy Exclusion Criteria: * Significant back, buttock or leg pain from causes other than lumbar central canal stenosis * Axial back pain only * Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level * Severe lateral recess stenosis * Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention * Prior decompressive surgery at index level (s) or fusion at any lumbar level * Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments * Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1 * Spondylolysis (pars fracture) * Significant degenerative lumbar scoliosis at index level(s) * Morbid obesity * Significant peripheral vascular disease * Active significant co-morbidity * Undergoing immunosuppressive therapy or long-term steroid use * Current spinal cord stimulator or implanted pain pump * Life expectancy less than 2 years * Evidence of substance abuse within the year * Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue