In short
TranS1 Inc., minimally invasive device company focused on lumbar spine surgery, has announced completion of the first head-to-head retrospective study comparing its proprietary AxiaLIF® pre-sacral interbody fusion procedure to ALIF (Anterior Lumbar Interbody Fusion). The combined review of both participating surgeons demonstrated improved fusion rates with AxiaLIF over ALIF but the difference in the rates were not statistically significant.
Background
TranS1 is a medical device company focused on designing, developing and marketing products to treat degenerative conditions of the spine affecting the lower lumbar region. TranS1 currently markets the AxiaLIF® family of products for single and two level lumbar fusion via a sacral approach, the VEO™ lateral access and interbody fusion system, and the Vectre™ and Avatar™ posterior fixation systems for lumbar fixation supplemental to AxiaLIF fusion.
Study
This study represents the use of AxiaLIF 1L (L5-S1) with pedicular fixation versus ALIF (L5-S1) with pedicular fixation. Follow up time points ranged from a minimum of two years to a maximum of 6 years for the AxiaLIF group and 2 years to 9 year follow-up for the ALIF group. There were 48 patients in each arm of the study.
Two independent spine surgeons evaluated 96 total patients at two year or greater follow up with thin slice CT scans. Strict radiographic criteria were employed to determine bridging bone between the vertebral bodies. Further, the AxiaLIF cohort experienced no serious adverse events, compared with the ALIF cohort, which reported two serious adverse events. Ten sites contributed patients to this study.
The study will be submitted for publication by lead author Peter G. Whang, MD, Associate Professor of Orthopaedics and Rehabilitation at Yale University, to a peer-reviewed spine journal. Preliminary data on a subset of patients was recently presented as a poster at the International Meeting of Spine Techniques (IMAST), which was held in Istanbul, Turkey on July 19-21.
Company comments
Ken Reali, President and Chief Executive Officer of TranS1, stated, “This study represents an important contribution to the growing base of clinical research on pre-sacral interbody fusion. TranS1 is committed to clinical studies demonstrating the safety, efficacy and cost effectiveness of AxiaLIF.”
Source: TranS1 Inc., Globe Newswire
