FDA Clears Expanded Indication for LDR’s ROI-C Cervical Cage

Austin, Texas-based spinal device firm LDR Holding Corp. received U.S. Food and Drug Administration (FDA) clearance for the ROI-C Cervical Cage for use with allograft. The device previously was cleared only for use with autogenous bone graft.

The indications for use of the LDR ROI-C Cervical Cage have been expanded to permit use with allograft. LDR presented clinical literature review data to the agency to investigate the risks and benefits associated with using allogenic bone graft with ROI-C. According to the company, the published clinical outcomes demonstrated that the use of allograft (i.e., cancellous and/or corticocancellous bone graft) in cervical interbody fusion devices to treat patients diagnosed with cervical degenerative disc disease poses no new risks to patients.

“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,” said Darrell C. Brett, M.D., a neurosurgeon at Northwest Spine and Laser Surgery in Portland, Ore. “I am pleased that use of allograft is now a cleared application.”

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 use the system. As stated in the device description in the cleared 510(k) summary, VerteBRIDGE 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.”

The ROI-C VerteBRIDGE anchoring plate, made of titanium alloy can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The anchoring plate locks securely in place to the PEEK implant via locking tabs on either side of the anchoring plate.
LDR’s primary products are based on its exclusive Mobi non-fusion and VerteBRIDGE fusion technology platforms and are designed for applications in the cervical and lumbar spine.

In August 2013, LDR received approval from the FDA for the Mobi-C cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease.