AxiaLIF system: minimally invasive device for presacral lumbar interbody spinal fusion.

Lumbar fusion is commonly performed to alleviate chronic low back and leg pain secondary to disc degeneration, spondylolisthesis with or without concomitant lumbar spinal stenosis, or chronic lumbar instability. However, the risk of iatrogenic injury during traditional anterior, posterior, and transforaminal open fusion surgery is significant. The axial lumbar interbody fusion (AxiaLIF) system is a minimally invasive fusion device that accesses the lumbar (L4-S1) intervertebral disc spaces via a reproducible presacral approach that avoids critical neurovascular and musculoligamentous structures. Since the AxiaLIF system received marketing clearance from the US Food and Drug Administration in 2004, clinical studies of this device have reported high fusion rates without implant subsidence, significant improvements in pain and function, and low complication rates. This paper describes the design and approach of this lumbar fusion system, details the indications for use, and summarizes the clinical experience with the AxiaLIF system to date.