The U.S. FDA has cleared the Spineology®, Inc. Rampart One Anterior Lumbar Interbody Fusion System.
Spineology Inc. describes itself as an innovator in anatomy-conserving surgery™, providing spinal technologies for surgeons and their patients. With its commitment to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery, the company specializes in surgical techniques that conserve spinal bone, ligament and muscle tissue.
Now Spineology is taking these principles into anterior spinal fusion procedures with Rampart One which is designed to minimize the traditional exposure and vascular retraction requirements that typify these procedures. The newly FDA cleared system includes both standard and oblique interbody device footprints each with integrated fixation screws.
Rampart One is manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material. This provides 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 artifact-free imaging.
“Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” said Dr. 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 Dr. Clifford Tribus of Madison, Wisconsin.
“Minimizing 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,” said John Booth CEO of Spineology.
Source: Business Wire