Vertos Medical News Story, Press Release

Vertos Medical Announces mild® Procedure Long-term Safety and Efficacy Data

Published September 11, 2018

Results from CMS-approved study demonstrate clinically meaningful and statistically significant improvements in mobility and reductions in pain at two-year follow-up

ALISO VIEJO, CA— Vertos Medical Inc., a leader in the development of innovative, minimally invasive treatments for lumbar spinal stenosis (LSS), today announced the publication of two-year data from a Centers for Medicare & Medicaid Services (CMS)-approved study, MiDAS ENCORE. The data affirms long-term safety and efficacy of the mild® lumbar decompression procedure, a clinically proven outpatient procedure that removes the cause of the 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 mild® procedure, which received broad coverage from CMS in 2016, has been performed on more than 20,0000 patients, and its safety and efficacy have been demonstrated in more than 13 clinical studies and over 25 publications. The new long-term data, which appears in the September 7, 2018 issue of Regional Anesthesia and Pain Medicine, the official publication of the American Society of Regional Anesthesia and Pain Medicine, showed excellent long-term durability and revealed no evidence of spinal instability or fracture for patients who had the mild® procedure. All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through two-year follow-up. Additionally, the mild® procedure had no device-or procedure-related serious adverse events, and a significantly lower rate of complications than other, more invasive spine interventions.

Authors of the journal article reporting the data, “Long-term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis with Neurogenic Claudication: Two-year Results of MiDAS ENCORE,” also noted that the mild® procedure is an excellent early spinal decompression intervention choice for patients with thickened ligamentum flavum. Thickened ligamentum flavum causes narrowing of the spinal canal, resulting in pain and numbness of the lower back, legs and buttocks. The study further revealed that LSS patients having additional back conditions such as a bulging disc, facet hypertrophy and foraminal narrowing also achieved statistically significant pain relief and improvement in mobility, noting that the presence of these conditions should not exclude a patient from being considered for the mild® procedure.

“Given the minimally invasive nature of this procedure, its safety profile, robust success rate, and durability of outcomes, mild® is an optimal early intervention for patients suffering from lumbar spinal stenosis,” said Dr. Peter Staats, a principal investigator of the MiDAS ENCORE study, lead author of the journal article and founder of the Division of Pain Medicine at the Johns Hopkins School of Medicine. “These results are exciting, and further reinforce the mild® procedure as a clinically validated, low-risk interventional pain treatment that directly removes the cause of stenosis, and provides long-term symptom relief.”

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