MiDAS ENCORE 2-Year, Level 1 Study: mild® provides clinically meaningful, statistically significant improvements in mobility, ODI, and pain reduction on the NPRS.
MiDAS ENCORE 2-Year, Level 1 Study: mild® is effective in treating patients with multiple stenosis types, including lateral and foraminal stenosis.
MiDAS ENCORE 2-Year, Level 1 Study: mild® has an equivalent safety profile to an ESI, but with lasting results. In this study, there were no statistically significant differences in the safety profile between study groups.
mild® is a minimally invasive procedure typically performed in an outpatient setting using local anesthetics and light sedation. The nature of the procedure carries that do not apply to receiving an epidural steroid injection.
Cleveland Clinic 1-Year Study: Patients’ average standing time improved from 8 min. to 56 min. and average walking distance increased from 246 ft. to 3,956 ft.
Cleveland Clinic 5-Year Study: 88% of mild® patients avoided back surgery for at least 5 years while experiencing significant symptom relief.
MiDAS ENCORE 2-Year Study: Patients reported an 85% patient satisfaction rate with the mild® Procedure.
HLF contributes up to 85% of spinal canal narrowing.
Several cross disciplinary leaders in the interventional spine community, representing many surgical and pain societies, have formed a consensus group to evaluate the current state of LSS diagnosis and treatment, and to make recommendations to guide clinical practice in this emerging area.
With new therapies emerging, you can now think differently about treating LSS patients. Move beyond palliative therapies and address a major root cause of LSS, without leaving any implants behind. If HLF is present, advance to mild® to provide patients long-term relief using a therapy that has a safety profile equivalent to an ESI, but with lasting results.
mild® Devices should only be used by physicians who have received appropriate training. It is important to read the Instructions for Use prior to device operation.
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Familiarity with fluoroscopic imaging techniques and expertise in the epidural space are key qualification requirements for performing mild®.
Publication— ASPN 2021 "Top 25 Abstract", 2021
Author— Pryzbylkowski P, Bux A, Chandwani K, et al.
Publication— Journal of Pain Research, 2021
Author— Pope JE, Deer TR, Falowski SM
Publication— Journal of Pain Research, 2021
Author— Deer T, Kim C, Wahezi SE, Qu H, Sayed D
Publication— Pain Practice, 2021
Author— Mekhail N, Costandi S, Nageeb G, et al.
Publication— Pain Management, 2020
Author— Jain S, Deer TR, Sayed D, et al.
Publication— Medical Devices (Auckland), 2020
Author— Mekhail NA, Costandi SJ, Armanyous S, et al.
Publication— Pain Practice, 2019
Author— Deer, TR, Grider JS, Pope JE, et al.
Publication— Pain Physician, 2016
Author— Benyamin RM, Staats PS
Publication— Pain Practice, 2015
Author— Udeh BL, Costandi S, Dalton JE, Ghosh R, Yousef H, Mekhail N.
Publication— Regional Anesthesia & Pain Medicine, 2018
Author— Staats PS, Chafin TB, Golovac S, et al.
Publication— Pain Physician, 2016
Author— Staats PS, Benyamin RM
Publication— Pain Practice, 2013
Author— Chen H, Kelling J
Publication— Pain Practice, 2012
Author— Brown LL
Publication— Pain Practice, 2012
Author— Mekhail N, Vallejo R, Coleman MH, Benyamin RM
Publication— Pain Physician, 2012
Author— Deer TR, Kim CK, Bowman RG, Ranson MT, Yee BS
Publication— Pain Practice, 2012
Author— Mekhail N, Costandi S, Abraham B, Samuel SW
Publication— The Clinical Journal of Pain, 2012
Author— Wong WH
Publication— The Clinical Journal of Pain, 2012
Author— Basu S
Publication— Pain Medicine, 2012
Author— Levy RM, Deer TR
Publication— Pain Management, 2012
Author— Deer TR
Publication— Journal of Neurosurgery: Spine, 2011
Author— Chopko BW
Publication— The Neuroradiology Journal, 2011
Author— Schomer DF, Solsberg D, Wong W, Chopko BW.
Publication— Neurosurgical Review, 2011
Author— Deer TR, Mekhail N, Lopez G, Amirdelfan K
Publication— Pain Physician, 2010
Author— Deer TR, Kapural L
Publication— Pain Physician, 2010
Author— Chopko BW, Caraway DL
Publication— Pain Physician, 2010
Author— Lingreen R, Grider JS
Vertos can assist with setting up claims and address any questions you may have. As a general notice, Vertos provides procedure-specific information about codes that may be used for procedures that employ our technology and products. Reimbursement methods vary by payer and site of service.
As commercial insurance coverage for the mild® Procedure varies by payer policy, we encourage providers to contact non-Medicare payers to confirm coverage prior to performing the procedure.
(855) 848-6453
Author— Peter Pryzbylkowski, MD
Epidural steroid injections (ESIs) have historically served as the standard of care (and an easy, early intervention) for lumbar spinal stenosis patients. But now we have mild®—a proven, well-studied, and safe solution that has improved the function, pain, and quality of life for my LSS patients with neurogenic claudication. So, when do we move on from ESIs? How do we introduce mild® as the standard of care for our stenosis patients? How do we ensure our colleagues value the safety and outcomes and, in turn, send us patients who could benefit?
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.
Vertos is an equal employment opportunity workplace committed to pursuing and hiring a diverse workforce. We strive to grow our team with highly skilled people who share our culture and values. We do not discriminate on the basis of sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, physical & mental disability, medical condition, genetic information, veteran status, or any other basis protected by federal, state or local law.
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 decompression for lumbar spinal stenosis: the impact of moving to Mild directly or after initial epidural steroid injection (ESI) failure on clinical performance – a six center retrospective report. Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.
