Evaluation of Interspinous Process Distraction Device (X-STOP) in a Representative Patient Cohort

The success level in the controlled IDE study that established the safety and efficacy of the X-STOP device was achieved in a representative patient cohort that did not necessarily meet all the strict requirements of the IDE plan. Nevertheless, the overall results were not good, suggesting that the ZCQ definition of success might not have captured the true outcome of surgical treatment with the X-STOP device.