Spinal technologies provider Spineology has secured clearance from the US Food and Drug Administration (FDA) for its anterior lumbar interbody fusion system, Rampart One.
The system reduces exposure and vascular retraction requirements that are usually observed in standard procedures for anterior spinal fusion.
It features standard and oblique interbody device footprints with integrated fixation screws.
Spineology CEO John Booth said: “Minimising exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs."
The variable angle and integrated guides of the lumbar interbody fusion system are said to allow minimum incision, while its oblique footprint is expected to help during limited or no vessel mobility.
The device is manufactured using Invibio Peek-Optima HA Enhanced material to deliver an improved osteoconductive surface for bone on-growth. It also offers the standard benefits of its predecessor Peek-Optima Natural, including a decrease of stress shielding and artifact-free imaging.
With a focus on procedural efficiency, minimum surgical morbidity, and patient recovery, the firm develops conserving spinal technologies for various anatomies such as spinal bone, ligament and muscle tissue.
In addition to Rampart fusions, the firm’s interbody portfolio includes Elite Expandable Interbody Fusion System.
The solution is designed to reduce neural retraction and insertion force while allowing a larger graft channel and controlled expansion.
Image: Spineology Rampart One. Photo: courtesy of Business Wire.