Percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) is a procedure that has been proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. PILD involves a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. It is generally described as a noninvasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, computed tomography) with the assistance of contrast media to identify and monitor the compressed area via epiduragram.
LSS is defined as the reduction of the cross-sectional area, or narrowing, of the lumbar spinal canal. It is usually caused by spinal degenerative conditions and is commonly found to be asymptomatic. LSS is subclassified into three broad categories: central stenosis, lateral stenosis, and spondylolisthesis. Central stenosis refers to a narrowing of the spinal canal across the anteroposterior diameter, the transverse diameter, or both. Symptomatic individuals typically present with symptoms of radicular leg pain or with neurogenic claudication (i.e., pain in the buttocks or legs on walking or standing that resolves with sitting down or lumbar flexion).
Although lumbar laminectomy is often considered the gold standard surgical treatment for LSS, PILD has been proposed as an alternative surgical treatment. However, there is a lack of adequately designed peer-reviewed literature or guidance from relevant medical societies to establish its safety and effectiveness. There is a need for additional clinical studies with sufficient follow-up, sample size, and relevant comparative control groups to establish the appropriateness of PILD for the treatment of central LSS.
Two devices (Vertos Medical and VertiFlex®, Inc.) have been approved by the Centers for Medicare & Medicaid Services (CMS) for Coverage with Evidence Development (CED). Additionally, as part of a Medicare Claims study, the Vertos Medical device is being investigated in a prospective, longitudinal analysis to evaluate individuals with LSS who are treated with a minimally invasive lumber decompression (MILD) procedure compared with individuals who receive an alternative interspinous process decompression (IPD) procedure.