LDR's ROI-A Oblique ALIF cage receives FDA marketing clearance

LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received 510(k) clearance from the United States Food and Drug Administration to market the ROI-A Oblique ALIF cage. The oblique cage complements its forerunner, the ROI-A ALIF cage, which is designed for direct anterior insertion. When used with the company's integrated VerteBRIDGE plating technology, both devices address the growing interest in the market for stand-alone lumbar fusion technology that reduces the need for additional anterior or posterior instrumentation. In addition to providing the benefits of ALIF surgery, a key feature of the ROI-A Oblique system is the opportunity to minimize the mobilization of the anterior vessels, without requiring the surgeon to consider a trans-psoatic lateral approach that may present increased neurologic risks and necessitate neuromonitoring.

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 company's 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.

Source LDR Holding Corporation