FDA Clears Spineology’s Rampart Duo Interbody Fusion System

Spineology Inc. announces FDA clearance of the Rampart Duo Interbody Fusion System. The Rampart Duo Interbody Fusion Device is the first device of its kind to combine PEEK, titanium, and graft containment mesh elements.
 
“Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh technology,” said John Booth, CEO of Spineology. “The 510(k) clearance of Rampart Duo opens the door to the commercialization of a family of hybrid PEEK and graft containment mesh implants designed for interbody fusion. The implant is a great addition to our anatomy-conserving product offering.”
 
“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” said Dr. Sandeep Kunwar, San Francisco, Calif.
 
“The device has been anatomically designed. The PEEK spacer blocks are positioned on the lateral aspects of the vertebral body, where the bone is naturally strongest, to provide solid anterior support,” added Dr. Michael Wang, Miami, Fla. “In addition, the central graft containment mesh allows for broad device deployment which increases graft footprint and facilitates conforming apposition of the graft to the endplate for fusion.”
 
“The small tubular retractor and streamlined instruments, including ones that allow for the placement of the device when a high iliac crest is present, may help preserve patient anatomy and limit operating room time,” said Dr. Craig Kuhns, Austin, Texas.

The Rampart Duo implant design includes PEEK spacer blocks that are positioned at each end of the device and a flexible porous graft containment mesh, which creates a central graft cavity. Following implantation, the porous graft containment mesh is filled with bone graft to deploy the device in the anterior-posterior direction, which allows for a wide graft footprint, and in the superior-inferior direction to provide conforming apposition with the vertebral endplates.