New Study Demonstrates mild® Procedure Five-Year Durability
88% of patients avoid surgical lumbar decompression for at least five years after receiving the mild® Procedure
ALISO VIEJO, Calif., May 18, 2021 /PRNewswire/ -- 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.1 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.
To view the article or for more information about Vertos Medical, please visit www.Vertosmed.com.
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.2 No major device-related complications have been reported in any clinical trial.3 Vertos Medical headquarters is located in Aliso Viejo, CA. To learn more about how the mild® Procedure treats LSS, go to www.Vertosmed.com.
1 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.
2 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.
3 Based on mild® Procedure data collected in all clinical studies. Major complications are defined as dural tear and blood loss requiring transfusion.
SOURCE Vertos Medical Inc.
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