LDR receives FDA approval for new lateral lumbar fusion system

4 September 2012 (Last Updated September 4th, 2012 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) approval to LDR's Avenue L lateral lumbar cage system, designed for lateral lumbar fusion.

LDR

The US Food and Drug Administration (FDA) has granted 510(k) approval to LDR's Avenue L lateral lumbar cage system, designed for lateral lumbar fusion.

Avenue L, which is implanted via a direct lateral trans-psoatic approach, features in-line, self-guided, zero-profile VerteBRIDGE plating technology to facilitate simplified cage insertion, and an inserter to protect anatomical structures, while implanting the cage and plating.

LDR president and CEO Christophe Lavigne said; "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."

Celebration Minimally Invasive Spine Institute founder Dr Faissal Zahrawi 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," Zahrawi said.

"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."

In addition to trans-psoatic approach, Avenue L has been implanted via a pre-psoatic approach without neurological monitoring in Europe, according to the company.

Centre Orthopedique SANTY orthopaedic surgeon Dr Alexis Faline said the centre has found that Avenue L to be a 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," Faline said.

"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."


Image: Avenue L with integrated VerteBRIDGE plating is used for performing lateral lumbar surgery. Photo: Courtesy of Business Wire.