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Home/Spine/LDR Introduces FDA-Cleared Lateral Lumbar Cage
Spine

LDR Introduces FDA-Cleared Lateral Lumbar Cage

September 5, 2012 2 min read Premium comments

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LDR Introduces FDA-Cleared Lateral Lumbar Cage
Avenue L Lateral Lumbar System / LDR Holding Corp.
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LDR Holding Corporation says it is the first company to introduce a lateral lumbar cage with integrated in-line plating into the U.S. market.

So says, Christophe Lavigne, president and CEO of LDR as the company announced FDA clearance of the Avenue L Lateral Lumbar Case System on September 4, 2012.

The system, according to the company,

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.

The system’s 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, according to a company press release, 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.”

Faissal Zahrawi, M.D., founder of the Celebration Minimally Invasive Spine Institute in Celebration, Florida implanted the first Avenue L lateral lumbar cage in the U.S. He said, “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.”

A French surgeon, Alexis Faline, M.D., of the Centre Orthopédique SANTY, 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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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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