Dallas, TX, November 13, 2012 – Pinnacle Spine Group, LLC, (“Pinnacle”) a Dallas, Texas-based company that designs, develops, manufactures and markets spinal implants and instruments, is pleased to announce the results of a new study, completed by an independent surgeon. Pinnacle received FDA clearance for the system in September 2012, and now has completed its first formal study proving the efficacy of the InFill Graft Delivery System.
The study was designed to evaluate the efficacy of a novel graft filling technique for maximizing interbody space and implant filling and optimizing endplate surface contact with the graft.
The results of the study demonstrate successful increase in interbody space and cage filling, with greatly enhanced endplate surface contact. Volumetric analysis 3-D CT scanning confirmed that up to 94% more graft material can be placed and contained between the vertebrae, including endplate surface contour filling and contact, when compared to traditional prepacking methods.
The study was conducted by Dr. Burak M. Ozgur MD FAANS and Erin Gleckman PA-C, in Newport Beach, CA. Dr. Ozgur has authored 25 studies in this field, contributed to more than 20 publications, and is a member of multiple associations.
The InFill Graft Delivery System was designed around the concept of placing autogenous graft material into the graft chamber of the implant in situ. It can be used to bulk up a pre-packed implant, or for a complete fill of the implant to maximize contact with the vertebral endplates.