New Study Demonstrates mild® Procedure Five-Year Durability
Source— Vertos MedicalMay 18, 2021
88% of Patients Avoid Surgical Lumbar Decompression for at Least Five Years After Receiving the mild® Procedure
ALISO VIEJO, Calif. — Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), announced the results today of an independent, retrospective cohort study that followed LSS patients receiving the mild® Procedure at the Cleveland Clinic between 2010 and 2015. The minimally invasive lumbar decompression (mild®) is a clinically proven outpatient procedure that removes a major root cause of stenosis through a portal the size of a baby aspirin and requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.
LSS study patients had hypertrophic ligamentum flavum (HLF), a thickening of the interspinous ligament that accounts for up to 85% of spinal canal narrowing. HLF may cause neurogenic claudication symptoms involving back or leg pain when standing or walking that is relieved when sitting or bending forward, as a contributing factor. Changes in pain level using the Numeric Rating Scale (NRS) and opioid medication utilization using Morphine Milligram Equivalent (MME) dose per day from baseline to 3-, 6-, and 12-months post-mild® Procedure were also collected, along with post-procedure complications.
According to the study, the mild® Procedure significantly decreased the incidence of surgical decompression at the same treatment level(s) as mild® intervention during five-year follow-up. Nine out of 75 patients required lumbar surgical decompression at the same level during the follow-up period, making the annual incidence of same-level lumbar-decompression surgery just 2.4%. Subjects experienced statistically significant pain relief and reduction of opioid medications utilization at 3, 6, and 12 months compared to baseline. There were no major complications reported.
The results of this retrospective study, “The Durability of Minimally Invasive Lumbar Decompression Procedure in Patients with Symptomatic Lumbar Spinal Stenosis: Long Term Follow-Up,” were published in the PAIN Practice online May edition. The study was conducted at the Cleveland Clinic by lead author Nagy Mekhail, MD, PhD, and Director of Evidence-Based Pain Management Research at Cleveland Clinic.
The mild® Procedure is approved nationally for Medicare and Medicare Advantage patients and private insurance coverage stands at over 90 million covered lives. Since the FDA clearance in 2006, the mild® Procedure has been performed on more than 30,000 patients and its safety and efficacy have been analyzed in 13 clinical studies and over 25 publications.
Vertos Medical Inc. is a medical device company committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis (LSS). Its proprietary technologies include the mild® instrumentation kit, which enables a safe, outpatient, minimally invasive, fluoroscopically guided therapeutic LSS treatment that requires no general anesthesia, no implants, and no stitches. LSS is primarily a degenerative, age-related narrowing of the lower spinal canal that causes symptoms of pain and numbness in the lower back, legs, or buttocks. The mild® Procedure treats this condition by restoring space in the spinal canal using specialized mild® devices to remove hypertrophic ligamentum flavum through a 5.1-mm treatment portal. Clinical studies show that the mild® Procedure can help LSS patients stand longer and walk farther with less pain. No major device-related complications have been reported in any clinical trial. Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how the mild® Procedure treats LSS, go to www.Vertosmed.com.
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