If You Have Lumbar Spinal Stenosis, There’s an Exciting New Option
July 20, 2017
This Ortho Spine News article describes lumbar spinal stenosis (LSS), its impact on patients and weighs the available treatment options. “People with severe lumbar spinal stenosis (LSS) often can’t stand longer than a few minutes or walk more than a few hundred feet without feeling severe pain,” the article states. LSS can be caused by bulging disk and/or enlargement of the ligaments in the spine, it continues.
“Until a few years ago, the only treatment options available were either of two extremes: conservative therapies or open spine surgery. However, conservative treatments, such as NSAIDS, physical therapy and epidural steroid injections, only work for a fraction of people.” The article adds that open spine surgery “works to relieve pressure on spinal nerves, but surgery and anesthesia may carry increased risk in older patients.”
The mild® Procedure which is explained to stand for minimally invasive lumbar decompression, is noted in the article as a new outpatient option. “It (mild®) is only an option for patients who have significant LSS due to thickening of the ligamentum flavum, or ligaments of the spine.”
Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.
Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012;12(6):417-425. doi:10.1111/j.1533-2500.2012.00565.x.
2012 data from Health Market Sciences report for Vertos Medical 2013.
Data on file with Vertos Medical.
Staats PS, Chafin TB, Golvac S, et al. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2-year results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43:789-794. doi:10.1097/AAP.0000000000000868.
Based on mild® Procedure data collected in all clinical studies. Major complications are defined as dural tear and blood loss requiring transfusion.
MiDAS ENCORE responder data. On file with Vertos Medical.
Jain S, Deer TR, Sayed D, et al. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020;10(5). https://doi.org/10.2217/pmt-2020-0037. Accessed June 1, 2020.
Deer TR, Grider JS, Pope JE, et al. The MIST Guidelines: the Lumbar Spinal Stenosis Consensus Group guidelines for minimally invasive spine treatment. Pain Pract. 2019;19(3)250-274. doi:10.1111/papr.12744.
Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009;18(5):679-686. doi:10.1007/s00586-009-0919-7.
Treatment options shown are commonly offered once conservative therapies (e.g., physical therapy, pain medications, chiropractic) are not providing adequate relief. This is not intended to be a complete list of all treatments available. Doctors typically recommend treatments based on their safety profile, typically prioritizing low risk/less aggressive procedures before higher risk/more aggressive procedures, but will determine which treatments are appropriate for their patients.
Although the complication rate for the mild® Procedure is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood or fat that migrates to the lungs or heart). Other risks include infection and bleeding, spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, warnings, precautions, and methods of use, please reference the devices’Instructions for Use.
Patient stories on this website reflect the results experienced by individuals who have undergone the mild® Procedure. Patients are not compensated for their testimonial. The mild® Procedure is intended to treat lumbar spinal stenosis (LSS) caused by ligamentum flavum hypertrophy. Although patients may experience relief from the procedure, individual results may vary. Individuals may have symptoms persist or evolve or other conditions that require ongoing medication or additional treatments. Please consult with your doctor to determine if this procedure is right for you.
Reimbursement, especially coding, is dynamic and changes every year. Laws and regulations involving reimbursement are also complex and change frequently. Providers are responsible for determining medical necessity and reporting the codes that accurately describe the work that is done and the products and procedures that are furnished to patients. For this reason, Vertos Medical strongly recommends that you consult with your payers, your specialty society, or the AMA CPT regarding coding, coverage and payment.
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Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence & association with symptoms: The Framingham Study. Spine J. 2009;9(7):545-550. doi:10.1016/j.spinee.2009.03.005.
Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain. 1998;14(2):148-151. doi:10.1097/00002508-199806000-00010.
Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up [published online ahead of print, 2021 May 4]. Pain Pract. 2021;10.1111/papr.13020. doi:10.1111/papr.13020
Friedly JL, Comstock BA, Turner JA, et al. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017;98(8):1499-1507.e2. doi:10.1016/j.apmr.2017.02.029
Pope J, Deer TR, Falowski SM. A retrospective, single-center, quantitative analysis of adverse events in patients undergoing spinal stenosis with neurogenic claudication using a novel percutaneous direct lumbar decompression strategy. J Pain Res. 2021;14:1909-1913. doi: 10.2147/JPR.S304997
Pryzbylkowski P, Bux A, Chandwani K, et al. Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections [published online ahead of print, 2021 Aug 4]. Pain Manag. 2021;10.2217/pmt-2021-0056. doi:10.2217/pmt-2021-0056
Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.
Mobility Matters: Low Back Pain in America, Harris Poll Survey, 2022. View data and full summary at knowyourbackstory.com.
Deer TR, Grider JS, Pope JE, et al. Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325-1354. Published 2022 May 5. doi:10.2147/JPR.S355285.