Vertos Medical, a medical device company, has released 12-week clinical data from its prospective, 75-patient MiDAS I (mild Decompression Alternative to open Surgery) study that further validated the safety and efficacy of 'mild' for the treatment of lumbar spinal stenosis (LSS).
According to Vertos the mild patients continued to experience improvement in pain, physical function and mobility in MiDAS I clinical study.
The study’s medical monitors also concluded that mild is safe, with no reports of major adverse events related to the procedure or devices.
Key outcome measures at 12 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).
Vertos said that 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.
Additionally, the data showed sustained improvement in quality of life (Physical Component Score, SF-12v2) and also sustained improvement in patient satisfaction, overall symptom severity and physical function (ZCQ).
The improvement in overall symptom severity and physical function (as with SF-12v2) was positive at both six and 12 weeks post-treatment.
James Corbett, president and CEO of Vertos, said: “The 12-week MiDAS I data represent a meaningful validation of mild’s role in the early treatment of LSS, where traditionally physicians have had to balance the risks of open, more invasive procedures for lasting effectiveness. We believe these new findings will further increase physician confidence in and adoption of mild in clinical practice.”