Medical Device Daily: Product Briefs - Vertiflex
December 14, 2011 - Medical Device Daily
VertiFlex (San Clemente, California) reported the completion of enrollment in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS). The results of the Superion trial will form the basis for a PMA approval application to the FDA. The Superion IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the Superion ISS compared to control arm X-STOP IPD in healthy adults suffering from at least six months of moderate lumbar spinal stenosis who have been unresponsive to conservative care. The national trial is being conducted at 31 leading spine surgery sites in the U.S. The study endpoint is the rate of overall success at 24 months. The Superion ISS was designed as an alternative to more invasive traditional spinal surgery. The Superion’s minimally invasive surgical technique is performed through a single, half-inch skin incision. Once in place, the device is intended to act as a support column to open the passageways that contain the spinal cord and nerve roots. This may reduce the compression on the nerves, resulting in potential pain relief in the leg, groin and buttocks, and the return to a more active lifestyle.