Innovator Spotlight: Vertos Plans to Expand Reach of Minimally Invasive Lumbar Decompression
Source— Medtech InsightJune 1, 2019
This four-page article by Medtech Insight highlights the new professional consensus guidelines that recommend Vertos Medical’s minimally invasive lumbar decompression (mild®) system as an alternative to epidural steroid injections (ESIs) for patients with lumbar stenosis. It also mentions Vertos Medical’s plan to raise more capital to expand its commercial operation so it can reach more patients that may benefit from the mild® Procedure.
“In the near term, Vertos is trying to bring mild® to patients with lumbar stenosis who are not candidates for surgery and instead are being treated with epidural steroid injections (ESIs) as well as patients who still had significant symptoms after trying epidural steroid injections (ESIs). About 400,000 people in the US fit into this category annually, but the ultimate market for mild® is probably much bigger than that, according to (Eric) Wichems (Vertos Medical’s CEO),” the article states.
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-
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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