LDR Announces FDA Clearance of the ROI-A® Oblique ALIF Cage
Christophe Lavigne, President and CEO of LDR, comments, "We are excited to strengthen our worldwide leadership in stand-alone device innovation by introducing the first oblique ALIF stand-alone cage into the U.S. market. This follows on the heels of our recent approval in China to market both the ROI-A ALIF and ROI-C® Cervical cages. The ROI-A Oblique represents the latest application of VerteBRIDGE plating technology, which has been successfully used in more than 17,000 cage implantations worldwide since 2008, with September 2011 marking the first month in which over 1,000 cages using VerteBRIDGE plating were implanted."
Dr. Federico P. Girardi, Associate Attending Orthopaedic Surgeon at the Hospital for Special Surgery and Associate Professor of Orthopaedics at Weill Cornell Medical College in New York, implanted the first ROI-A Oblique ALIF cage in the U.S. and shares the companys enthusiasm about the product. "A critical aspect of ALIF surgery is gaining access to the disc, especially at the L4-L5 level, where there may be significant concerns about management of the anterior vessels through a direct anterior approach and navigating the nerves within the psoas through a direct lateral approach. LDR has acknowledged and addressed these challenges with an innovative addition to its product line. The ROI-A Oblique ALIF cage serves a previously unmet need in lumbar surgery, and allows me to deliver better care to my patients."
The oblique cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a direct anterolateral approach so that the implantation may be achieved with less exposure than may be required to place a traditional ALIF cage or even contemporary stand-alone systems with screws that must be inserted at divergent angles. The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures while implanting the cage and plating. Clinical evaluation of the ROI-A Oblique cage began in France in 2009 with over 150 cases completed prior to its market introduction in the United States.
LDR was founded in 2000 by partners Christophe Lavigne, Hervé Dinville and Patrick Richard in Troyes, France. Currently headquartered in Austin, TX, LDR has experienced rapid growth through product portfolio expansion and an increasingly global presence. LDR develops unique implantable spine devices and instrumentation designed to support the clinical goals of surgery while making procedures easier to perform. More information is located at www.ldrholding.com.