Medtronic, Inc. (Medtronic), is planning to complete clinical trial entitled “Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease “ for DIAM Spinal Stabilization System in December 2011. The study will assess the short and long-term effectiveness and patient perception of benefit with the use of a DIAM Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5. This phase IV trial is being conducted in Belgium, Germany, Italy, Spain, Switzerland, UK.
The randomized, open label, parallel assignment, efficacy study currently recruiting approximately 268 participants. The principal investigator of the study is Ferdinand A. Krappel, MD Medizinisches Zentrum Kreis Aachen.
The DIAM Spinal Stabilization System is intended for use with minimally invasive surgical techniques. It provides flexible support to the lumbar spine while treating degenerative disc disease. The DIAM acts as a spacer which when placed between two spinous process restores the natural height of the disc, taking the pressure off the intervertebral disc and associated structures, and allows the nerve to exit freely from the spinal cord while maintaining normal movement of the spine. The device is made of a hardened silicone covered with a polyethylene sock and has two ligatures, which allow it to be secured in place between the two spinous processes.