ALISO VIEJO, Calif.–(BUSINESS WIRE)–Medical device company Vertos Medical Inc. has announced that its mild procedure was the subject of eight clinical presentations at the American Society of Regional Anesthesia and Pain Medicine’s (ASRA) 2010 Annual Pain Medicine Meeting, November 18-21 in Phoenix. Authored by a group of distinguished pain physicians from across the country, the presentations covered a range of clinical data demonstrating mild’s safety and efficacy for the treatment of lumbar spinal stenosis (LSS).
“The growing body of clinical data on mild has built a solid foundation of evidence that the procedure and the devices are safe and effective for the early treatment of LSS”
In “MiDAS I (mild Decompression Alternative to Open Surgery): Comprehensive Follow-up of a 78 Patient Prospective, Open Label, Multi-Center Clinical Study,” David L. Caraway, M.D., Ph.D. (St. Mary’s Pain Relief Center, Huntington, W. Va.) presented six-month follow-up data from the MiDAS I trial. He reported that mild patients experienced a statistically and clinically significant reduction in pain as measured by the Visual Analog Score (VAS), the Zurich Claudication Questionnaire (ZCQ) and the SF-12v2® Quality of Life Survey. Moreover, patients showed statistically significant and clinically relevant improvement in physical function and mobility as measured by the Oswestry Disability Index (ODI), ZCQ and SF-12v2 instruments. No device or procedure related adverse events were reported.
“These data are remarkable in that a significant positive response was achieved in all four validated outcomes instruments,” said Dr. Caraway. “We are also encouraged to see consistent improvement continuing at weeks six, 12 and 26, indicating that mild is a therapeutic option that has the potential to offer lasting relief for LSS sufferers.”
Another presentation, chosen by ASRA as one of three “Best of Meeting Abstracts,” compared the previously published, positive six-week data from MiDAS I to six-week data from MiDAS II, an open-label, single-arm, multi-center prospective clinical study of 55 patients. Author Stanley Golovac, M.D. (Space Coast Pain Institute, Merritt Island, Fla.) reported that patient outcomes using the VAS, ODI, ZCQ and SF-12v2 instruments were comparable between the two studies, with both studies showing a significant improvement in mobility and a significant reduction in pain, six weeks following the mild procedure. He also concluded that mild is safe, confirming that no device or procedure related adverse events occurred in either study.
mild’s safety was also validated in a presentation by Nagy A. Mekhail, M.D., Ph.D. (Cleveland Clinic, Cleveland). In a retrospective review of approximately 300 mild patient cases, Dr. Mekhail stated that there were no serious device or procedure related adverse events reported at follow-up ranging from acute to one year. He concluded that mild is safe and offers an early LSS treatment option following failed conservative therapy as well as an option for those who either cannot tolerate or choose not to proceed to more invasive surgical treatment.
“The growing body of clinical data on mild has built a solid foundation of evidence that the procedure and the devices are safe and effective for the early treatment of LSS,” said James M. Corbett, president and chief executive officer of Vertos. “We believe these findings suggest a significant role for mild in the LSS treatment continuum as a new therapeutic alternative for patients who have only had palliative or open surgical treatment options in the past.”
In addition to the clinical data presented by Drs. Caraway, Golovac and Mekhail, similarly positive findings from other mild studies were unveiled at the meeting by Timothy R. Deer, M.D. (The Center for Pain Relief, Charleston, West Va.), Jay S. Grider, D.O., Ph.D. (Frankfort Regional Medical Center, Frankfort, Ky.) and Amol Soin, M.D. (The Ohio Pain Clinic, Centerville, Ohio).
mild is an image-guided procedure used to treat patients with LSS, a condition diagnosed in 1.2 million patients annually in the United States.1 A less invasive alternative to open or endoscopic surgery, mild safely and therapeutically reduces pain and increases mobility while maintaining structural stability.
About Vertos Medical Inc.
Vertos Medical was founded to advance the treatment of patients suffering with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal. Its proprietary platform technologies include mild, which offers a therapeutic intervention to treat LSS and achieve lumbar spine decompression. For more information, visitwww.vertosmed.com.
* Vertos mild is FDA cleared for treating lumbar spinal stenosis.
1 Derived from the Longitudinal Medicare Database.