Medical device company Vertos Medical Inc. has announced the unveiling of 12-week clinical data from its prospective, 75-patient MiDAS I (mild Decompression Alternative to open Surgery) study that further validate the safety and efficacy of mild for the treatment of lumbar spinal stenosis (LSS). Consistent with the positive six-week study results released in March and May, the new MiDAS I data demonstrate that mild patients continued to experience statistically significant improvement in pain, physical function and mobility 12 weeks following treatment. The study's medical monitors also concluded that mild is safe, with no reports of major adverse events related to the procedure or devices.
“We believe these new findings will further increase physician confidence in and adoption of mild in clinical practice.”
The new MiDAS I results were presented by study Co-Medical Monitor David Caraway, M.D., Ph.D. (St. Mary's Pain Relief Center, Huntington, W. Va.) at the International Spine Intervention Society meeting in Maui, Hawaii on July 17.
"This new data is quite encouraging, as it shows us that mild is able to provide LSS patients with lasting, statistically significant improvement across all key outcomes measures," said Dr. Caraway. "With mild, physicians and patients now have an earlier, safer alternative for lumbar spine decompression that achieves sustained relief without the traditional risk profile."
Key outcome measures at twelve weeks included changes in Visual Analog Score (VAS), which measures pain; changes in Oswestry Disability Index (ODI), which assesses functional ability; as well as patient-reported responses to the SF-12v2® Quality of Life Survey and Zurich Claudication Questionnaire (ZCQ). The latter are widely accepted tools for measuring relative change in patient symptom severity, physical function as well as overall satisfaction with the results of the intervention.
The data showed that MiDAS I participants achieved: