The Rampart One Standard anterior lumbar interbody fusion (ALIF) device (Spineology) has been granted FDA clearance, allowing it to be used with or without supplemental fixation.
The Rampart One ALIF interbody fusion system is an anatomy-conserving technology, a press release states. The system includes both standard and oblique interbody devices, each with integrated fixation screws and is designed to minimise vascular retraction and exposure to maximise safety. Additionally, Rampart One is manufactured from Invibio PEEK-OPTIMA hydroxyapatite (HA) Enhanced material to support bone on-growth.
The company hopes this stand-alone clearance will provide additional momentum as they prepare for the full market release of the Rampart One ALIF interbody fusion system.
The US FDA cleared the Rampart One anterior lumbar interbody fusion system in June 2017.
“Minimal retraction and minimal exposure are very important for the anterior approach. The Rampart One instruments work collinear with the access, providing surgeons the ability to keep the incision to a minimum,” says Jeremy Shore (Boston, USA). “Additionally, divergent fixation screw angles and midline screw placement keep vascular retraction to a minimum.”
“Advanced biomaterials are showing great promise in enhancing patient outcomes. It’s very exciting to have access to an implant like Rampart One which is constructed from PEEK-OPTIMA HA Enhanced”, Clifford Tribus (Madison, USA) comments.
PEEK-OPTIMA HA Enhanced provides improved osteoconductive surfaces for bone on-growth while preserving the traditional benefits of PEEK-OPTIMA Natural including a modulus of elasticity similar to that of human bone, reduced stress shielding and artifact-free imaging.