Vertos Medical, a manufacturer of orthopedic medical devices, has released positive results from its US IRB I Patient Outcomes Trial, a prospective, investigational review board-approved, 75-patient study of Mild for the treatment of lumbar spinal stenosis (LSS).
The six-week clinical data have shown that patients treated with Mild experience statistically and clinically significant improvement in both pain and functional ability. The data also confirmed Mild’s safety, with no reports of patient complications related to the procedure or the devices.
As presented by study co-medical monitor David Caraway of St Mary’s Pain Relief Center, Huntington, the key outcome measured 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% 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. Caraway said that the latter is noteworthy, as a FDA 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. These findings are consistent with the results of a separate, recently published acute safety study of Mild, also presented as part of the CME meeting by Timothy Deer.
Vertos Medical develops a minimally invasive method for lumbar spine decompression to treat patients with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal. Its platform technology, called Mild, is the least invasive surgical procedure for treating LSS, with no implants left behind.