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LDR Receives 510(k) Clearance For ROI-C Cervical Cage

LDR announced that it has received 510(k) clearance for the ROI-C Cervical Cage. 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 this 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 US 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.

Dr. Cho shares, “The innovative VerteBRIDGE technology combined with well-designed instrumentation and the straight anterior mini-open technique provides a very effective solution for treating my patients. I was impressed with the speed and ease of plate insertion.”

Dr. Hoffman notes, “The implant’s anatomical design and available sizing options ensures that I can obtain great bone-implant contact and primary stability with immediate loading. The procedure is straightforward and the instrumentation is simple and easy to use.”

The ROI-C represents an evolution of LDR’s MC+ implant that has been successfully used in more than 5,000 cases worldwide since 2002. Like the original MC+ implant, the ROI-C cage features a domed superior surface to better match the shape of the endplate, without requiring the removal of important structural vertebral bone, and is available in a variety of footprints and heights to restore the stability of the spine. While the MC+ features a flat plate inserted at a 50° angle into the lower vertebra, the chief technological advancement of the ROI-C is the integration of VerteBRIDGE plating technology, which is comprised of curved plates that lock into both the upper and lower vertebrae and are introduced parallel to the plane of the disc. VerteBRIDGE plating technology was first introduced in the company’s very successful ROI-A system in 2008.

Clinical evaluation of the ROI-C began in France in April, 2009 with over 350 cases completed worldwide prior to its market introduction as a cervical cage in the United States.