Minimally Invasive Lumbar Decompression (mild®) Procedure: What Is It and Is It Right for Me?
April 14, 2021
Are you one of over two million patients suffering from lumbar spinal stenosis (LSS) annually nationwide? If so, you’re likely experiencing pain or numbness in your lower back when standing upright; pain, numbness, heaviness or tingling in your upper legs or buttocks when walking and pain when sleeping. The pain can become more common the older you get. In fact, lumbar spinal stenosis (LSS) is prevalent in about 20% of patients ages 60+ nationwide. Temporary relief is often found when sitting or bending forward, or by curling into a fetal position when lying down.
There are, however, other ways to relieve this pain and get back to what matters to you most! If your current treatment for lumbar spinal stenosis (LSS) isn’t providing you adequate relief, consider minimally invasive lumbar decompression (mild®) as your next step.
What does minimally invasive lumbar decompression (mild®) mean?
Minimally invasive lumbar decompression is an outpatient procedure that relieves pressure on the spine. Like a drinking straw with a kink in it, the spinal canal can narrow and compress the spinal canal nerves in the lower back. To restore space in the spinal canal and reduce the compression of the nerves, a mild® Doctor uses an imaging machine and specialized tools to remove small pieces of bone and thickened ligament.
What is the difference between mild® and my current pain management care?
Unlike most pain management treatments that are frequently repeated, minimally invasive lumbar decompression is generally a one-time procedure that may provide lasting relief for leg and back pain associated with lumbar spinal stenosis (LSS). The first course of action from your doctor may include conservative treatments such as pain medication, physical therapy or chiropractic care. While their safety profiles are also strong, these treatments are sometimes temporary and aren’t always effective for everyone.
Another course of action your doctor may recommend is an epidural steroid injection (ESI). These injections typically bring temporary relief, but do not address the root cause of lumbar spinal stenosis (LSS). Up to 85% of spinal canal narrowing is caused by the buildup and thickening of ligament that compresses the nerve. Effective treatment requires restoring space by thinning the ligament. Therefore, repetitive ESIs may just mask the pain in the short-term and only delay patient care.
Minimally invasive lumbar decompression, on the other hand, reduces pressure on the spinal nerves. It has a safety profile similar to epidural steroid injections (ESIs), but with lasting results. In fact, mild® demonstrated excellent long-term durability with significant improvements in both pain and mobility through two years.
What is the difference between minimally invasive lumbar decompression (mild®) and traditional back surgery?
The mild® Procedure is different from traditional back surgery because it is an outpatient procedure that does not require general anesthesia, implants, stitches, steroids or opioids. Typically completed in less than an hour, mild® can be performed through a single, tiny incision smaller than the size of a baby aspirin (5.1 mm) using only local anesthetic and light sedation and leaves no implants behind. After the mild® Procedure, patients are typically able to resume normal activity within 24 hours with no restrictions, which is not the case with traditional back surgery.Unlike other more invasive treatments, such as spacer implants, fusion or traditional back surgery, mild® doesn’t eliminate future treatment options or other therapies for back pain. If symptoms persist or evolve, both conservative and more invasive therapies remain available.
Does the minimally invasive lumbar decompression (mild®) Procedure work?
mild® has helped thousands of patients achieve lasting relief from back pain. In a one-year study performed at the Cleveland Clinic, after the mild® Procedure, patients were able to increase their standing time from eight minutes to 56 minutes with less pain and their average walking distance from 246 feet (walking to the mailbox) to 3,956 feet (walking around the mall). Clinical data from a MiDAS ENCORE 2-Year Study finds mild® provided patients with lasting pain relief and increased mobility.
With over 30,000 lumbar spinal stenosis (LSS) treated and a complication rate of less than 0.1%, mild® is a minimally invasive procedure that may be able to provide you with lasting relief. Complete a short survey to determine if minimally invasive lumbar decompression may be an effective treatment option. Print or save your results and discuss with a mild® Doctor.
To learn more about this condition or diagnosis, please consult an interventional pain doctor or use our interactive Find a mild® Doctor tool to locate a mild® Doctor near you.
Disclaimer – This is not a replacement for a medical diagnosis, a recommendation for treatment or medical advice. Please consult a doctor to determine personal health issues and treatment recommendations.
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.
Vertos Medical cannot guarantee coding, coverage, or payment for products or procedures. View our Billing Guide.
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Hall S, Bartleson JD, Onofrio BM, Baker HL Jr, Okazaki H, O’Duffy JD. Lumbar spinal stenosis. Clinical features, diagnostic procedures, and results of surgical treatment in 68 patients. Ann Intern Med. 1985;103(2):271-275. doi:10.7326/0003-4819-103-2-271.
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.