Vertos mild Lumbar Decompression System Proving Itself in Trial

Vertos Medical of Aliso Viejo, California is reporting on positive results from a study evaluating the safety and efficacy of the firm’s mild system for treatment of lumbar spinal stenosis. The minimally invasive system uses a trocar to install a portal under a fluoroscope, which then allows bone and tissue removal tools to be introduced to help decompress the area.
Some details of the study from the press release:

As presented by study Co-Medical Monitor David Caraway, M.D., Ph.D. (St. Mary’s Pain Relief Center, Huntington, W. Va.), key outcome measures at six weeks included changes in Visual Analog Score (VAS), which measures pain, and Oswestry Disability Index (ODI), which assesses functional ability. The study protocol defined success as a minimum two-point VAS improvement from baseline. The data showed that 67 percent of study participants met this success criterion, with an average improvement of 3.6 points from baseline across all patients. In addition, patients achieved an average ODI improvement from baseline of 17.9 points. The latter is noteworthy, said Caraway, as a U.S. Food and Drug Administration panel on orthopedic and rehabilitation devices has given guidance that a minimum 15-point change in ODI score from baseline is clinically significant.
Dr. Caraway also noted that the data confirmed mild’s safety profile, with no dural tears, blood transfusions or other procedure or device-related complications having occurred.

Press release: VERTOS MEDICAL’S PROSPECTIVE OUTCOMES STUDY DEMONSTRATES EFFICACY, VALIDATES SAFETY PROFILE OF mild®…
Product page: Vertos mild Devices…