FDA Clearance of ROI-C Lordotic Cervical Cage

LDR officials announce that the company has received 510(k) clearance from the United States Food and Drug Administration to market the ROI-C Lordotic Cervical Cage. The ROI-C Lordotic Cervical Cage adds to the company’s market leading stand-alone portfolio and compliments the existing ROI-C anatomically shaped cage introduced in 2009. When used with the company’s integrated VerteBRIDGE plating technology, both cages offer a zero profile, stand-alone construct for fusion in the cervical spine. The design of the ROI-C Lordotic Cervical Cage provides an additional option during surgery allowing surgeons to treat patients with more varied anatomy and reduces the need for thick cervical plates that may contribute to dysphagia, or difficulty swallowing.

Design of the shapes of both of the ROI-C Cervical Cages and their integrated plating system are to match the patient’s anatomy and provide initial and long-term stability. Delivery of the self-guided, curved plating is in the plane of the disc through a direct anterior approach, so that the achievement of surgery is with less exposure than may be required to implant a traditional cervical plate, or even contemporary stand-alone systems with screws that require insertion at oblique and challenging angles. The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures when placing the cage and VerteBRIDGE Plating.

Christophe Lavigne, president and CEO of LDR, comments, “We are excited to strengthen our worldwide leadership in stand-alone device innovation by introducing the ROI-C Lordotic Cervical Cage into the U.S. market. LDR has led the way in providing surgeons with a broad selection of implant geometries for stand-alone cervical and lumbar fusions. The ROI-C Lordotic Cervical Cage represents the latest application of VerteBRIDGE Plating technology which has been successfully used in more than 25,000 cervical and lumbar cage implantations worldwide since 2008.”

Dr. Robert Jackson, chief of neurosurgery at Mission Hospital Regional Medical Center and assistant clinical professor of neurosurgery at the University of California Irvine, implanted the first ROI-C Lordotic Cervical Cage in the United States and shares the company’s enthusiasm about the product: “A critical aspect of anterior cervical fusion is providing excellent stability through good bone-implant contact and primary stability with immediate loading. That is best achieved by matching the cage to a patient’s specific anatomy. LDR has acknowledged and addressed these challenges with an innovative addition to its product line to address anatomies that are more varied. LDR’s cervical offering addresses the anatomical challenges I encounter and allows me to deliver better care to my patients.”