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LDR announces expanded indication for its cervical cage device

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LDR Holding Corporation recently announced its ROI-C Cervical Cage has received FDA clearance to expand the indications of the device to include use with allograft.

Previously, the device was cleared only for use with autogenous bone graft. Company representatives presented the FDA with clinical literature review data to investigate the risks and benefits associated with the use of allogenic bone graft and the ROI-C. According to a press release from the company, the published clinical outcomes showed allograft use in cervical interbody fusion devices did not present new risks to patients diagnosed with cervical disc degeneration disease.

According to the release, the system is indicated for skeletally mature patients diagnosed with degenerative disc disease of the cervical spine who also have single-level radicular symptoms from C2-T1.

Reference:

www.ldr.com.