Vertos Medical Completes Enrollment in MOTION Study of mild® Procedure, a Minimally Invasive Treatment for Lumbar Spinal Stenosis
December 3, 2019
ALISO VIEJO, CA— Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), today announced the completion of enrollment in its nationwide, multicenter MOTION Study of its mild® Procedure. The novel prospective, randomized controlled study will collect clinically validated, patient-reported pain and function outcome measures, as well as real world quality of life data using Fitbit activity trackers. The study enrolled approximately 150 patients who were 50-80 years of age from 19 sites across the United States and patients will be followed for two years. It is the second large,multi-center study, randomized controlled trial that has been done on the mild® Procedure.
The mild® Procedure is a clinically proven outpatient LSS treatment that removes the cause of stenosis through a portal the size of a baby aspirin. It requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.
“We are pleased that we were able to reach full enrollment so quickly and look forward to seeing the six-month results next year,” said Dr. Tim 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 will provide high quality data using validated pain and function outcomes measures, but we are most excited about the Fitbit activity data. This data is critical to demonstrating the real-world quality of life improvements patients experience with the mild® Procedure, ”added Dr. Deer.
The mild® Procedure has been performed on more than 25,000 patients and its safety and efficacy have been analyzed in more than 13 clinical studies and 20 publications. Study data has shown clinically meaningful and statistically significant mobility improvement and pain reduction, with no serious procedure complications in any clinical trial.“Vertos believes that it is critical for clinicians and patients to have access to high quality data in order to make good clinical decisions, so we are excited that enrollment is complete for the MOTION study,” said Eric Wichems, president and CEO of Vertos Medical. “We want to thank all the physicians in our study that have actively enrolled patients.”
For more information about Vertos Medical, please visit www.vertosmed.com.
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.
