Vertos Medical Inc. (“Vertos Medical”) is committed to complying with all applicable laws governing the sale and marketing of, and price reporting for, our products, and to maintaining the privacy of patient health information. Accordingly, Vertos Medical has established a Comprehensive Compliance Program which enables Vertos Medical to ethically and legally promote its products and to avoid activities that may be viewed as improper inducements to increase the purchase or use of its products.
Pursuant to California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”), which requires pharmaceutical companies (and medical device companies) to adopt a compliance program in accordance with the Office of Inspector General (“OIG”) for the United States Department of Health and Human Services April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Program Guidance”) and policies for compliance with the Advanced Medical Technology Association “Code of Ethics on Interactions with U.S. Health Care Professionals” (“AdvaMed Code”) and Medical Device Manufacturers Association “Revised Code of Conduct on Interactions with Healthcare Providers” (“MDMA Code”) within six months of any update or revision of the AdvaMed Code or MDMA Code. The AdvaMed Code was revised and restated effective January 1, 2020. The MDMA Code was revised and adopted by the Medical Device Manufacturers Association on October 23, 2019.
Vertos Medical has established a Healthcare Compliance Program in accordance with the OIG Compliance Program Guidance and has policies in place to foster compliance with the AdvaMed Code and MDMA Code. Consistent with the requirements of the California Compliance Law and as part of the Healthcare Compliance Program, Vertos Medical has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Vertos Medical may give or otherwise provide to an individual medical or health professional in California on an annual basis from January 1 to December 31. The $2,000 limit does not include the value of items expressly excluded by California law, including product samples given to physicians and healthcare professionals intended for free distribution to patients.
The items and activities covered by the law and Vertos Medical policy are primarily directed to the dissemination or communication of medical and scientific information as a resource for health professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Vertos Medical website. This limit represents a spending maximum, and the amount spent per medical or health professional may be significantly less than the maximum amount. Vertos Medical has established an internal monitoring system designed to help ensure compliance with the annual spending limit in California as well as other spending limits across the United States.
Vertos Medical is committed to conducting business activities in compliance with applicable laws, rules and regulations, and following the highest ethical standards in its interactions with all medical and health professionals and organizations. It is the policy of Vertos Medical that all interactions with medical and health professionals and organizations that are made on behalf of Vertos Medical are consistent with ethical business practices and socially responsible industry conduct. Vertos Medical’s Healthcare Compliance Program and related policies and procedures are an expression of this core value, and are intended to provide guidelines for complying with the law for all Vertos Medical personnel and agents.
To the best of its knowledge and based on a good faith understanding of the statutory requirements, Vertos Medical has established a Healthcare Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. Vertos Medical has tailored its Healthcare Compliance Program to meet the specific needs of Vertos Medical and continuously assesses the effectiveness of the Healthcare Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and other similar spending limits across the United States. Therefore, subject to the limitations described above, Vertos Medical declares that, based upon current tracking and monitoring systems, Vertos Medical is materially in compliance with its Healthcare Compliance Program and applicable law, including the established annual spending limits in California for the period of January 1, 2020, through December 31, 2020.
For a written copy of Vertos Medical’s Healthcare Compliance Program description or this declaration, please contact us. To report compliance questions or potential compliance concerns, Vertos Medical encourages you to please contact our independent compliance division.
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. 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.