LDR Receives Clearance for Lumbar Cage System

Medical device company LDR has received 510(k) clearance from the U.S. Food and Drug Administration for its Avenue L Lateral Lumbar Cage System. According to the company, the system’s features include in-line, self-guided VerteBrudge plating technology to facilitate simplified cage insertion and zero-profile, intradiscal, integrated fixation through a direct, minimally invasive approach.

“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,” said Christophe Lavigne, president and CEO of LDR. “VerteBridge plating technology . . . has been successfully used in more than 25,000 cage implantations worldwide since 2008.”

“Direct lateral lumbar surgery is the perfect application of LDR’s integrated VerteBridge plating,” offered Faissal Zahrawi, M.D., founder of the Celebration Minimally Invasive Spine Institute in Celebration, Fla., and who implanted the first Avenue L lateral lumbar cage in the United States. “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 require insertion at divergent angles. The system includes an inserter designed to protect 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 psoas muscles are the pair of muscles on either side of the lumbar spine, descending down to the loin area. The Avenue L lateral cage has been used in Europe since 2010 with over 300 cases completed, according to LDR.

“The VerteBridge plating provides immediate, additional stability without having to alter my exposure,” said Alexis Faline, M.D., orthopedic surgeon at the Centre Orthopédique Santy, France, and one of the initial users in Europe “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.”

Headquartered in Austin, Texas, LDR is a 12-year-old company that produces implantable spine devices and surgical instruments.