LDR has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avenue L Lateral Lumber Cage system, which is implanted via a direct lateral trans-psoatic approach for lateral lumbar fusion.
Avenue Lumber Cage system includes an in-line, self-guided, zero-profile VerteBRIDGE plating technology to facilitate simplified cage insertion as well as an inserter to protect anatomical structures, while implanting the cage and plating.
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 added.
The company said in addition to trans-psoatic approach, Avenue L has been implanted via a pre-psoatic approach without neurological monitoring in Europe.
Center Orthopedique SANTY orthopaedic surgeon Dr. Alexis Faline said the center 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 added.
"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."