LDR First With Oblique ALIF Stand-Alone Cage (written by Walter Eisner @ OTW)
LDR has received clearance from the FDA to market the company’s ROI-A Oblique ALIF Cage.
Christophe Lavigne, president and CEO of LDR, said in the November 1 press release that the clearance makes LDR the first company to introduce an oblique ALIF stand-alone cage into the U.S. market.
Reduces Need for Additional Instrumentation
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 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, according to the company, 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.
Lavigne noted the company’s 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.”
Girardi: “Serves Unmet Need”
Federico Girardi, M.D., 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. Said Girardi, “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 company says the oblique cage and curved 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 instrumentation including an inserter that, says the company, 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 U.S.