Observational study on mild demonstrates acute safety of procedure in treatment of LSS

Vertos Medical Inc.Feb 24 2010

Medical device company Vertos Medical Inc. has reported that an observational study on mild, published in the January/February 2010 issue of the peer-reviewed journal Pain Physician, has demonstrated the acute safety of the procedure in the treatment of lumbar spinal stenosis (LSS). The study, conducted by leading pain physicians Timothy Deer, M.D. (The Center for Pain Relief, Charleston, West Va.) and Leonardo Kapural, M.D., Ph.D. (Cleveland Clinic, Cleveland, Ohio), found no reports of patient complications related to the mild devices or technique.

Study data was collected from a survey conducted across 14 physicians at 12 U.S. centers. The survey called for a retrospective chart review of 90 consecutive LSS patients treated with mild between January 2008 and July 2009. The data collected included any complications and/or adverse events that occurred during or immediately following the mild procedure, before discharge. Based on a review of the survey results, the study authors concluded that there were no reports of dural puncture or tear, blood transfusion, nerve injury, epidural bleeding or hematoma among the patients treated.

Moreover, Drs. Deer and Kapural compared the mild safety data to that previously published on alternative minimally invasive and open surgical treatments for LSS. They concluded that, although informal, their initial assessment of mild suggests a “much better” safety profile as compared to the other surgical procedures. They also indicated that treating patients with the ultra-minimally invasive mild procedure could “significantly decrease risks while reducing costs.”

Commenting on the study data, Dr. Deer said, “These findings are a significant validation of the acute safety profile and potential future clinical value of mild, especially when compared to current surgical alternatives. We believe the new mild approach offers physicians an opportunity to treat their LSS patients earlier, with less risk and at less expense, which – in the current health care environment – is a big win for patients, physicians and payors alike.”

Vertos Medical President and Chief Executive Officer Jim Corbett agreed with the study’s impact. “This observational data, which was gathered by two of the country’s most esteemed pain medicine experts and recognized by the peer-reviewed journal Pain Physician, underscores the growing physician confidence we are seeing in mild. With its acute safety profile now firmly demonstrated, we have moved yet another step towards establishing mild as the primary treatment for LSS after medical management but before more invasive procedures.”