Pioneer Surgical Technology has announced the FDA granted approval to proceed to IDE pivotal study of the NuBac Nucleus Replacement Device for the spine.
The NuBac implant system utilises an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimising extrusion risk. The NuBac implant is made of peek-optima material and, according to Pioneer, it offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.
Spinal disc arthroplasty surgery includes total disc replacement (TDR) and nucleus replacement procedures. Both techniques seek to relieve discogenic back pain caused by degenerative disc disease, restore stability and flexibility to the affected spine segment. Nucleus replacement procedures are commonly less invasive, more tissue preserving, and less bridge-burning than TDR surgery.