Vertos Medical Announces Results Showing Meaningful Mobility Improvement Following mild® Procedure
Source— Vertos Medical
Published
February 22, 2022
Level 1 Study Demonstrates Functional Improvement for Patients Treated with mild® Procedure as First-Line Therapy in a Real-World Setting
ALISO VIEJO, Calif. [February 22, 2022] — Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), announced today the publication of 1-year results from a Level 1 prospective, randomized controlled study showing meaningful mobility improvement following the mild® Procedure, a minimally invasive lumbar decompression therapy for lumbar spinal stenosis. At 1 year, patients treated with mild® plus conventional medical management (CMM) showed a 16-point mean change in functional improvement as measured by the Oswestry Disability Index (ODI) and were able to walk 250% longer than before the procedure.
The Oswestry Disability Index (ODI) is widely used to assess symptoms and severity of low back pain in terms of disablement, and the degree to which back or leg pain impacts functional activities. These one-year results are consistent with those of the prior Level 1 study, and add to the body of evidence demonstrating that the mild® Procedure can provide mobility improvement along with quality-of-life improvements for patients.
Additional 1-year data for patients receiving the mild® Procedure plus CMM vs CMM alone include:
250% improvement in walking time compared to baseline prior to the procedure
0% device- or procedure-related adverse or serious adverse events
Less than 8% of mild® patients required a subsequent intervention
The mild® Procedure 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.
The MOTION Study is a prospective, randomized controlled study, designed to evaluate functional improvement for patients treated with the mild® Procedure as first-line therapy in a real-world setting. In the study, patients were treated with the mild® Procedure plus CMM or CMM alone, reflecting real-world treatment progression and patient care. The study enrolled 155 patients who were 50-80 years of age from 19 sites across the United States. It is the second largest, multi-center, randomized controlled study that has been done on the mild® Procedure.
“We are excited to see this study mirroring the robust results of prior studies, now being demonstrated in a real-world setting,” said Dr. Timothy Deer, an interventional pain specialist, president and CEO of The Spine and Nerve Center of the Virginias and national principal investigator for the MOTION Study. “This study provides high-quality data using validated functional outcome measures, including the incorporation of a walking test that allows us to demonstrate the real-world, quality-of-life mobility improvements patients experience with the mild® Procedure,” added Dr. Deer.
“Given the minimally invasive nature of this procedure, its safety profile, robust success rate, and durability of outcomes, mild® has proven to be effective as first-line treatment for patients suffering from lumbar spinal stenosis,” said Eric Wichems, president and CEO of Vertos Medical. “These results are exciting, and demonstrate the additive benefit of the mild® Procedure for a patient when CMM alone does not work.”
The mild® Procedure is approved nationally for Medicare and Medicare Advantage patients and private insurance coverage stands at over 97 million covered lives. Since the first FDA clearance in 2006, the mild® Procedure has been performed on more than 45,000 patients and its safety and efficacy have been analyzed in 16 clinical studies and over 30 publications.
Listen to Dr. Deer discuss the study and why mild® is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic LSS.
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.
The mild® Procedure is a minimally invasive treatment for lumbar spinal stenosis. 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. All qualified applicants will receive consideration for employment without regard to sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender identity, 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 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 here.
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.
