Oxiplex® /SP Gel is intended to be used as an adjunct to surgery during lumbar laminectomy, laminotomy and discectomy procedures. The device inhibits the formation of peridural fibrosis and dural adhesions that may otherwise contribute to postoperative radicular pain and/or neurological dysfunction.

The primary objective of this pivotal study is to evaluate the efficacy of Oxiplex ® / SP Gel in the reduction of postoperative pain and symptoms and to evaluate the safety of applying Oxiplex® /SP Gel during single level spinal discectomy performed to reduce symptoms associated with unilateral herniation of a lumbar intervertebral disc, in subjects undergoing their first surgeries for such conditions. The level of response in the treated and non-treated subject groups will be evaluated.

Preoperative, intraoperative, and postoperative factors will be assessed in the evaluation of efficacy and safety. Efficacy issues will be assessed relative to the amount of leg pain and physical symptoms as evaluated with the use of the Lumbar Spine Outcomes Questionnaire developed at Johns Hopkins University . Safety issues will be assessed in terms of adverse events, evaluations of abnormalities in clinical hematology/chemistries, evaluation of wound site (e.g., presence of pain, tenderness or infection), prolongation of operative procedure time, occurrence of excess bleeding at the operative site following device implantation, tissue trauma or other intraoperative event attributed to the device implantation.