Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Inclusion Criteria: * Skeletally mature subjects age 25-70 years, inclusive * Chronic lower back pain for at least six months * Failure to respond to at least six months of non-operative conservative management * Oswestry Disability Index (ODI) at time of evaluation of at least 30 points * Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1 Exclusion Criteria: * Radicular pain by history or evidence of pain neurological deficit within the past one year. * Previous surgery performed on the lumbar spine * Current or history of symptomatic spinal stenosis * Current or history of osteoporotic or tumor-related vertebral body compression fracture * Current or history of vertebral cancer or spinal metastasis * Current or history of spinal infection * Metabolic bone disease * BMI greater or equal to 40 * Any radiographic evidence of other important back pathology * MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1 * Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * Subjects who are bed bound * Demonstrates 3 or more Waddell's signs of Inorganic Behavior * Any evidence of current systemic infection