Discover why leading interventionalists offer mild® to treat Lumbar Spinal Stenosis (LSS).
What mild® Physicians are Saying
Clinically Significant Outcomes for mild®
Long-Term Efficacy
MiDAS ENCORE 2-Year, Level 1 Study: mild® provides clinically meaningful, statistically significant improvements in mobility, ODI, and pain reduction on the NPRS.
Effective for Patients with Comorbidities
MiDAS ENCORE 2-Year, Level 1 Study: mild® is effective in treating patients with multiple stenosis types, including lateral and foraminal stenosis.
Safety Profile Equivalent to an ESI
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.
Patients Stand 7x Longer
Cleveland Clinic 1-Year Study: Average standing time improved from 8 min. to 56 min.
Patients Walk 16x Farther
Cleveland Clinic 1-Year Study: Average walking distance improved from 246 ft. to 3,956 ft.
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.
The Next Step to Providing Patients Lasting Results Could Be mild®
Remove The Problem. Leave Nothing Behind.
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® Procedural Benefits
Efficient Outpatient Procedure
No general anesthesia, implants, stitches, steroids or opioids required
Can be performed through a single, tiny incision under still- and live-image fluoroscopic guidance, which allows streamlined access to multiple levels and sides, reducing non-treating time
Low Risk Profile
Clinically proven safety profile equivalent to an ESI
No device- or procedure-related serious adverse events or complications reported in any clinical trial
Removes the Problem
mild® removes a major root cause of neurogenic claudication by debulking the hypertrophic ligamentum flavum, which reduces the compression of the nerves
Quick Recovery Time
Patients typically resume normal activity within 24 hours with no restrictions
Doesn’t Burn Bridges
No implants and no major structural anatomy altered
No co-occurring or future treatment options eliminated
mild® Procedural Benefits
Visualizing the mild® Procedure
Lumbar decompression performed through an incision smaller than the size of a baby aspirin (5.1 mm).
Watch the mild® Procedure
Strong Safety Profile
Safety Profile Equivalent to an ESI
Decompression performed posterior to the epidural space with no general anesthesia, implants, stitches, steroids or opioids required. Generally performed with local anesthetic and light sedation.
Efficient Outpatient Procedure
Can be performed through a single, tiny incision under still-and live-image fluoroscopic guidance, which allows streamlined access to multiple levels and sides
Patients typically resume normal activity within 24 hours with no restrictions
Maintains Structural Anatomy
Does not significantly alter the structural anatomy of the spine or eliminate future treatment options
Low Complication Rate
Adverse event rate <0.1% in more than 30,000 commercial cases
No device- or procedure-related serious adverse events or complications reported in any clinical trial
Compatible for patients with existing risk factors
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.
Training & Education
In collaboration with the nation’s leading mild® practitioners, we provide training and education to physicians and practices across the U.S.
Mastering the mild® Procedure- Training Objectives:
1
Identify and Treat the Right Patients
2
Establish Comfort and Clinical Efficiency
3
Refine Your Treatment Algorithm
Familiarity with fluoroscopic imaging techniques and expertise in the epidural space are key qualification requirements for performing mild®.
Request Training
Request Training
Body of Evidence: Two Level 1 Studies. Two-Year Durability.
Vertos Medical makes it simple to set up claims, so you can get back to treating your patients.
mild® is nationally covered by all Medicare and Medicare Advantage plan types
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.
Learn more about the mild® Procedure through didactic lectures, discussions and a compendium of case reviews from other leading experts by clicking below.
The Vertos mild® Devices are a sterile, single-use system of specialized lumbar decompression surgical tools used to remove small portions of the lamina and preferentially resect and debulk the thickened ligamentum flavum.
Click here to view the “Minimally Invasive Lumbar Decompression: A Review of Indications, Techniques, Efficacy and Safety” and references for this chart.
All lumbar levels, including L5-S1, are treatable with mild®. The physician should decide which levels to treat based on symptom and imaging assessment.
Patients typically resume normal activity within 24 hours with no restrictions after having the mild® Procedure. Many patients notice an improvement in their ability to stand longer and walk farther within a few days, as shown in the Functional Outcome Improvement charts from the Cleveland Clinic Study at 1-Year below, and in some cases immediately after having mild®.
For some patients, it’s a matter of rebuilding strength after being deconditioned by the debilitating effects of LSS, such as a limited ability to walk. In these cases, it may take three to twelve months post-mild® to achieve full benefits.
Yes. mild® doesn’t cause major anatomical changes and therefore doesn’t burn bridges if other treatments are required in the future. mild® does not eliminate any treatment options.
The physician would need to assess the patient’s health and disease state to identify if the patient is a candidate. Typically, if the physician can access the HLF safely, mild® can be performed.
mild® is currently reimbursed in the outpatient hospital or ASC setting.
Yes, mild® is covered by Medicare (all ages, all plan types, including Medicare Advantage) nationwide and many commercial insurers are currently reviewing payment policies. View our .
In collaboration with the nation’s leading mild® practitioners, we provide training and education to physicians and practices across the US. Visit the Training & Education section above to learn more.
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Vertos Medical provides a variety of print and digital resources to mild® providers to help educate their patients and staff. Please contact your local representative or contact us for assistance.
Our long-term vision is to create global patient access to the mild® therapy. We are actively planning for international expansion and have a CE Mark, but are not yet ready to initiate our efforts. To stay updated on our progress, please visit our website’s newsroom.
To better serve the healthcare community, a CED study was conducted to obtain national Medicare coverage for the mild® Procedure. During the time that we focused on those efforts, active selling was temporarily paused until the current national Medicare coverage policy was issued. There were no product defects, safety issues or regulatory concerns associated with the pause.
mild® in the Media
The latest news stories, blog posts, company news releases and media information about the mild® Procedure.
Vertos Medical Announces ASC Reimbursement Increase for the mild® Procedure
Source— Vertos Medical
Effective January 1, 2021, the Centers for Medicare and Medicaid Services (CMS) has increased Ambulatory Surgery Center (ASC) reimbursement for the mild® Procedure. The national average ASC reimbursement for CPT 0275T will increase by 41%.
Benyamin, R., et al. (2016), mild® is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial, Pain Physician, 19: 229-242, ISSN 1533-3159.
Mekhail, Nagy, et al. (2012) Functional and Patient-Reported Outcomes in Symptomatic Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 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, et al. for the MiDAS ENCORE Investigators. (2018), 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.
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., et al. (2020), Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety, Pain Manag., Published online ahead of print: 1 Jul 2020, https://www.futuremedicine.com/doi/10.2217/pmt-2020-0037.
Deer, TR, Grider, JS, Pope, JE; For the Lumbar Spinal Stenosis Consensus Group. (2019) The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment. Pain Pract. 2019;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.