We covered LDR’s announcement earlier this year of the FDA’s clearance of its ROI-A™ ALIF device. Now the spinal implant company has announced FDA 510(k) clearance for its Avenue® L Lumbar cage system which it says represents the pinnacle of lateral lumbar fusion, featuring 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.
LDR was founded in 2000 by partners Christophe Lavigne, Hervé Dinville and Patrick Richard in Troyes, France and is now, like so many medtech companies, headquartered in Austin, Texas.
LDR says its 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.
Dr. Faissal Zahrawi, founder of the Celebration Minimally Invasive Spine Institute in Celebration, Florida implanted the first Avenue L lateral lumbar cage in the U.S. and shares the company’s enthusiasm about the product, “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.”
Dr. Alexis Faline, Orthopaedic Surgeon in the Centre Orthopédique SANTY (France), one of the initial users in Europe, shares, “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.”
Christophe Lavigne, President and CEO of LDR, comments, “We are thrilled to strengthen our portfolio of innovative products and increase our zero-profile spinal fixation options by introducing the first lateral lumbar cage with integrated in-line plating into the U.S. market. The state of the art Avenue L lateral cage represents the latest application of VerteBRIDGE plating technology, which has been successfully used in more than 25,000 cage implantations worldwide since 2008.”
Source: LDR Medical, Business Wire