The US Food Drug Administration (FDA) has cleared Spineology’s Rampart One anterior lumbar interbody fusion system.
Rampart One is designed to minimise the exposure and vascular retraction requirements associated with traditional anterior spinal fusion procedures. The system includes both standard and oblique interbody device footprints each with integrated fixation screws.
“Minimising exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs. We are very excited about this approval and look forward to entering the anterior market in the near future,” says John Booth.
“Variable angle instrumentation and integrated guides are collinear with the access, providing the surgeon the ability to keep the incision to a minimum,” says Jeremy Shore of Boston, Massachusetts.
“For instances where there is limited to no vessel mobility, the Rampart One Oblique footprint is an excellent option,” adds Clifford Tribus of Madison, Wisconsin.
Rampart One is manufactured from Invibio PEEK-Optima HA Enhanced material. This is designed to provide an improved osteoconductive surface for bone on-growth while preserving the traditional benefits of PEEK-Optima natural including a modulus similar to bone, reduced stress shielding and artefact-free imaging.