LDR Gets FDA Approval For Cervical Device

The Food and Drug Administration has approved Austin, TX, surgical device maker LDR's newest product.

The ROI-C cervical cage helps in standalone cervical fusion surgeries, making it less necessary to use thick cervical plates that contribute to dysphagia or difficulty swallowing.

“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," says LDR CEO Christophe Lavigne. "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 Hoffman of Orthopaedics Northeast in Fort Wayne, Ind. and Dr. Paul Henry Cho of The Center for Neurological Disorders in Ft. Worth were the first to implant the ROI-C in the United States.

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.

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.

LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore stability and mobility to patients and to make spine surgery more reproducible and easier to perform.