FDA clears ROI-A Oblique anterior lumbar interbody fusion system


The Food and Drug Administration (FDA) has cleared the ROI-A Oblique anterior lumbar interbody fusion (ALIF) cage (LDR) for stand-alone lumbar fusion. When used with LDR’s integrated Vertebridge plating technology, both devices reduce 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 minimise the mobilisation of the anterior vessels, without requiring the surgeon to consider a trans-psoatic lateral approach that may present increased neurologic risks and necessitate neuromonitoring.

Federico P Girardi, associate attending orthopaedic surgeon at Hospital for Special Surgery and associate professor of Orthopaedics at Weill Cornell Medical College in New York, USA, implanted the first ROI-A Oblique ALIF cage in the USA, he commented, “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.”

Christophe Lavigne, LDR president and CEO, commented, “We are excited to strengthen our worldwide leadership in stand-alone device innovation by introducing the first oblique ALIF stand-alone cage into the US 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.”

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.