The Avenue L Lateral Lumber Cage System from LDR (Austin, TX) received 510(k) clearance, opening the way for the first lateral lumbar cage with integrated in-line plating to be sold in the U.S. The device has been on the market in Europe since 2010.
Designed to stabilize lumbar spinal segments to promote fusion, the device offers the company’s proprietary in-line, self-guided VerteBRIDGE plating technology, which has been used in more than 25,000 cage implantation procedures since it debuted in 2008.
The Avenue L Lateral Lumbar Cage System is intended for intervertebral body fusion of the lumbar spine, from the L2 to S1 vertebrae. The intervertebral cages in the device are made from PEEK OPTIMA Lii (ASTM F2026) and titanium alloy markers to enhance X-ray imaging. The system must be used with posterior supplemental fixation such as pedicle screws.
From the press release:
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 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.
Press release: LDR Announces FDA Clearance of the Avenue® L Lateral Lumbar Cage System