Healthcare Industry News:  Spinal Stenosis 

Devices Orthopaedic Neurosurgery

 News Release - February 22, 2022

Vertos Medical Announces Results Showing Meaningful Mobility Improvement Following mild(R) Procedure

Level 1 study demonstrates functional improvement for patients treated with mild® Procedure as first-line therapy in a real-world setting

ALISO VIEJO, Calif., Feb. 22, 2022 -- (Healthcare Sales & Marketing Network) -- 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.

To view the article or for more information about Vertos Medical, please visit https://www.vertosmed.com/the-motion-study-a-randomized-controlled-trial-with-objective-real-world-outcomes-for-lumbar-spinal-stenosis-patients-treated-with-the-mild-procedure-1-year-results/.

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

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