DESCRIPTION
Image-guided minimally invasive lumbar decompression (IG-MILD) is being investigated as a novel percutaneous procedure for decompression of the central spinal canal in individuals with lumbar spinal stenosis. In contrast to surgical decompression, this procedure is performed solely under fluoroscopic guidance (e.g., without endoscopic or microscopic visualization of the work area). The procedure is indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation, should it be required.
During the IG-MILD procedure, the epidural space is filled with contrast medium under fluoroscopic guidance. Using a 6-gauge cannula that is clamped in place with a back plate, single use tools (portal cannula, surgical guide, bone rongeur, tissue sculpter, trocar) are used to resect thickened ligamentum flavum and small pieces of lamina. The tissue and bone sculpting is conducted entirely under fluoroscopic guidance, with additional contrast media added throughout the procedure to aid visualization of the decompression. The process is repeated on the opposite side for bilateral decompression of the central canal. The devices utilized for the procedure are not intended to be used near the lateral neural elements and are contraindicated for disc procedures.
POLICY
Image-guided minimally invasive lumbar decompression is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
This procedure is indicated for central stenosis only, without the capability of addressing nerve root compression or disc herniation, should it be required. Due to the unknown impact of these limitations on health outcomes, randomized controlled studies in appropriate patients are needed to compare this novel procedure with the established alternatives. Although studies have been initiated, no published evidence is available at this time to evaluate the efficacy of image-guided percutaneous lumbar decompression.
The Vertos mildŽ tool kit initially received 510(k) marketing clearance as the X-Sten MILD Tool Kit (X-Sten Corp.) from the U.S. Food and Drug Administration (FDA) in 2006, with intended use as a set of specialized surgical instruments to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions. Vertos mildŽ tool kit instructions for use state that the devices are not intended for disc procedures but rather for tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina. These devices are not intended for use near the lateral neural elements and remain dorsal to the dura using image guidance and anatomical landmarks.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2010). Image-guided minimally invasive lumbar decompression (IG-MLD) for spinal stenosis 7.01.126). Retrieved July 8, 2010 from BlueWeb. (8 articles and/or guidelines reviewed)
Chou, R., Loeser, J. D., Owens, D. K., Rosenquist, R. W., Atlas, S. J., Baisden, J., Carragee, E. J., et al. (2009). Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: An evidence-based clinical practice guideline from the American Pain Society. Spine, 34 (10), 1066-1077.
Deer, T. R. and Kapural, L. (2010). New image-guided ultra-minimally invasive lumbar decompression method: The mild(R) procedure. Pain Physician, 13 (1), 35-41.
ORIGINAL EFFECTIVE DATE: 12/11/2010
MOST RECENT REVIEW DATE: 12/11/2010
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