Huntington, W.Va.-based Marshall University Joan C. Edwards School of Medicine joins an FDA study determining the efficacy and safety of Premia Spine's Total Posterior Spine System compared to traditional lumbar fusion, reports Huntington News.
Four insights:
1. The TOPS System aims to restore motion of the spine in all directions by allowing the two vertebrae to continue moving, rather than locking them in a spinal fusion.
2. Thirty healthcare organizations in the U.S. are participating in the FDA investigational device exemption study.
3. Sixty-seven percent of patients in the study will undergo surgery with the TOPO System, with the rest undergoing a lumbar spinal fusion.
4. Marshall University is now enrolling patients for the study. Surgeries will be performed at Cabell Huntington Hospital in Huntington, W.Va.