VertiFlex Inc (VertiFlex), a company focused in spinal market, is planning to complete the ISISS trial for Superion by June 2011. The aim of the trial is to evaluate the safety and effectiveness of the Superion ISS compared to the X-STOP IPD device. The trial is for healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study is being conducted across the US.
The proposed prospective, multi-center, randomized, open label, active control, parallel assignment clinical trial is currently recruiting approximately 400 participants. The study endpoint is the rate of overall subject success at 24 months.
The Superion is a interspinous spacer titanium metal implant that is delivered through a small 12-15 millimeter incision in the patient’s back. The implant is placed percutaneously between the spinous processes without the need to cut paraspinal muscles. The interspinous spacer is designed to distract (open) the foramen, where the nerve endings pass away from the center of the spinal region and into the legs. These devices may also unload the intervertebral disc and they may limit spinal extension (the position the spine takes on when bending backward).
The study official title is A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex Superion Interspinous Spacer (ISS) to the X-STOP Interspinous Process Decompression (IPD) System in Patients With Moderate Lumbar Spinal Stenosis.