Study results indicate that patients treated with Vertos Medical's mild® procedure for lumbar spinal stenosis showed a change in functional improvement at one year. Treated patients were also able to walk 250% longer than before the procedure.
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 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.
MOTION 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.
Source: Vertos Medical Inc.