ROI-C Lordotic Cervical Cage gets FDA clearance

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LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, has announced that it has received FDA 510(k) 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 and 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.

The shapes of both of the ROI-C Cervical Cages and their integrated plating system are designed to match the patient’s anatomy and 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 that 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 and challenging angles.

The system features designed instrumentation including an inserter that protects anatomical structures when placing the cage and VerteBRIDGE plating.


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, he said: “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 more varied anatomies. LDR’s cervical offering addresses the anatomical challenges I encounter and allows me to deliver better care to my patients.”

 

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