FDA clears Avenue L Lateral Lumbar Cage System

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The US Food and Drug Administration (FDA) has given 510(k) clearance to LDR to market its Avenue L Lateral Lumbar Cage System. 

Avenue L features enhanced in-line, self-guided Vertebridge plating technology to facilitate simplified cage insertion and zero-profile, intradiscal, integrated fixation all through a direct, minimally invasive approach.

Faissal Zahrawi, founder of the Celebration Minimally Invasive Spine Institute in Celebration, Florida implanted the first Avenue L lateral lumbar cage in the USA, he commented: “Direct lateral lumbar surgery is the perfect application of LDR’s integrated Vertebridge plating. I appreciate that the in-line plating can be deployed in the plane of the disc without requiring additional or prolonged retraction of the Psoas. Avenue L with integrated Vertebridge plating gives me confidence in the stability of the cage, increases my treatment options and allows me to deliver better care to my patients.”


The Avenue L cage and self-guided, curved Vertebridge plating are delivered in the plane of the disc through a minimally invasive direct lateral approach, so that the implantation may be achieved with less exposure than may be required of other lateral systems with integrated 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.


Avenue L has been implanted via a pre-psoatic approach without neurological monitoring in Europe, and is also compatible with the direct lateral trans-psoatic approach common in the United States. The Avenue L lateral cage has been used in Europe since 2010 with over 300 cases completed.


Alexis Faline, orthopaedic surgeon in the Centre Orthopédique Santy in France, one of the initial users in Europe, said: “I have found Avenue L to be an extremely versatile and reliable system. The cage design includes a generous surface area which may help to promote solid fusion, and a wide variety of sizes that addresses diverse patient anatomy. The Vertebridge plating provides immediate, additional stability without having to alter my exposure. Avenue L has been an important addition to my surgical practice for lumbar degenerative conditions, through a pre-psoatic approach, and I am very pleased with the clinical results that I have observed in my patients.”

 

 

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