LDR Announces FDA Clearance of the ROI-C Cervical Cage

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AUSTIN, Texas–(BUSINESS WIRE)–LDR, a total spine solution company, announced today that it has begun to market its ROI-C™ cervical cage following 510(k) clearance from the United States Food and Drug Administration. The ROI-C cage, when used with the company’s integrated VerteBRIDGE™ plating technology, offers a zero profile, stand-alone construct for fusion in the cervical spine. ROI-C addresses the growing interest within the market for stand-alone cervical fusion technology that reduces the need for thick cervical plates that may contribute to dysphagia, or difficulty swallowing.

The anatomical shape of the ROI-C cage and its integrated plating system are designed to provide initial and long-term stability. The self-guided, curved plating is delivered in the plane of the disc through a direct anterior approach, so the surgery can be achieved with less exposure than may be required to implant a traditional cervical plate or even contemporary stand-alone systems with screws that must be inserted at oblique angles. The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures when placing the cage and VerteBRIDGE plating.

Christophe Lavigne, CEO of LDR, comments, “The entry of the ROI-C cervical cage into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies. The product builds on the success we’ve had with the MC+ device and VerteBRIDGE plating to provide surgeons with yet another innovative and reliable solution.”

Dr. Gregory A. Hoffman of Orthopaedics Northeast, Fort Wayne, Indiana and Dr. Paul Henry Cho, M.D. of The Center for Neurological Disorders, Ft. Worth, Texas were the first to implant the ROI-C in the United States.

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