The STEPS - Totalis™ Trial

Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a
radiographically-confirmed diagnosis of central canal stenosis, with or without mild or
moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all
inclusion/exclusion criteria, including ≥6 months of non-operative management.

Patients included in the clinical investigation will return for follow-up visits at 1 week
for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months
post-treatment to collect data for evaluation of safety and effectiveness.

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