10.22.15
Austin, Texas-based LDR Holding Corporation has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the ROI-C cervical cage for use with allograft. Previously, the device was cleared only for use with autogenous bone graft.
“The addition of on-label clearance for the use of allogenic bone graft in the ROI-C is a positive step in the FDA acknowledging how the cage can best be used to treat well-indicated patients. I am pleased that use of allograft is now a cleared application,” said Darrell C. Brett, M.D., a neurosurgeon at Northwest Spine and Laser Surgery in Portland, Ore.
The ROI-C cervical cage system is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. The cage is to be used with autogenous or allogenic bone graft.
Supplemental internal fixation is required to properly utilize this system. As specifically stated in the device description in the cleared 510(k) summary, Vertbridge Plating can be inserted to “obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct.”
“It is a positive step forward that this expanded indication for the stand-alone ROI-C Cervical Cage reflects the common surgical practice of using allograft bone in cervical cages to promote fusion,” said LDR President and CEO Christophe Lavigne. “For patients who may not be good candidates for disc replacement with the Mobi-C cervical disc and therefore may turn to cervical fusion as an alternative, the ROI-C is designed to be inserted via a minimally invasive, direct access approach to the disc while avoiding the need for the traditional cervical plate with four screws. In keeping with our minimal implant volume (MIVo) surgery philosophy, we believe that there is inherent benefit in performing the least amount of surgery necessary and minimizing the implanted materials required to achieve the desired outcome. This is very attractive to both surgeons and patients.”
LDR makes devices that treat spine disorders.
“The addition of on-label clearance for the use of allogenic bone graft in the ROI-C is a positive step in the FDA acknowledging how the cage can best be used to treat well-indicated patients. I am pleased that use of allograft is now a cleared application,” said Darrell C. Brett, M.D., a neurosurgeon at Northwest Spine and Laser Surgery in Portland, Ore.
The ROI-C cervical cage system is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. The cage is to be used with autogenous or allogenic bone graft.
Supplemental internal fixation is required to properly utilize this system. As specifically stated in the device description in the cleared 510(k) summary, Vertbridge Plating can be inserted to “obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct.”
“It is a positive step forward that this expanded indication for the stand-alone ROI-C Cervical Cage reflects the common surgical practice of using allograft bone in cervical cages to promote fusion,” said LDR President and CEO Christophe Lavigne. “For patients who may not be good candidates for disc replacement with the Mobi-C cervical disc and therefore may turn to cervical fusion as an alternative, the ROI-C is designed to be inserted via a minimally invasive, direct access approach to the disc while avoiding the need for the traditional cervical plate with four screws. In keeping with our minimal implant volume (MIVo) surgery philosophy, we believe that there is inherent benefit in performing the least amount of surgery necessary and minimizing the implanted materials required to achieve the desired outcome. This is very attractive to both surgeons and patients.”
LDR makes devices that treat spine disorders.