Pain Practice journal publishes Vertos mild procedure clinical study data on LSS

Medical device company Vertos Medical Inc. has announced that one-year post-study follow-up data on its mild procedure for lumbar spinal stenosis (LSS) have been published in the peer-reviewed journal Pain Practice. In "Long Term Results of Percutaneous Lumbar Decompression mild for Spinal Stenosis," authors concluded that the mild procedure is safe and provides long-term pain relief and improved mobility in patients with LSS.

The article reviews 12-month post-study follow-up data on 58 patients from the 11-center MiDAS I (mild® Decompression Alternative to Open Surgery) clinical trial. The authors found that mild patients continued to experience a statistically significant and clinically relevant reduction in pain and improvement in mobility at one year, according to a number of patient-reported outcomes measures. In addition, 74 percent of patients remained satisfied with the overall results of their mild procedure. No device or procedure-related serious adverse events were reported.

"These one-year findings are very positive news for both physicians and patients, as they demonstrate mild's value as an early therapeutic option in the LSS treatment continuum," said Nagy Mekhail, M.D. Ph.D., director of evidence-based pain management research at the Cleveland Clinic and lead author of the Pain Practice article. "Historically, LSS patients have had two primary treatment options: conservative care, which may generate either temporary or no response, or open surgical procedures, which carry a higher degree of risk. With mild, we have a safe, effective and lasting therapeutic alternative that finally fills the gap between these two options and addresses a significant unmet need in the management of patients with symptomatic spinal stenosis."

Vertos previously announced the one-year mild post-study follow-up data at the annual Cleveland Clinic symposium on March 7, 2011. Since then, the data have been presented at a number of professional society meetings over the last several months, including the annual meetings of the American Academy of Pain Medicine, the American Society of Interventional Pain Physicians, and the West Virginia Society of Pain Physicians. At several of these meetings, mild research, including the one-year post-study follow-up data, has received top awards for scientific excellence.

"The Pain Practice article represents an important addition to the body of published, peer-reviewed research on mild. We are pleased about the growing recognition of the solid clinical evidence supporting the procedure," said James M. Corbett, president and chief executive officer of Vertos Medical. "The research, which now includes long-term data, has been a key driver of physician adoption and patient access to the mild procedure"

Source: Vertos Medical Inc.