Wenzel Spine has received US Food and Drug Administration (FDA) approval to market its VariLift-LX product. The interbody fusion device can now be marketed for stand-alone use in the lumbar spine.
VariLift-LX is indicated to be implanted in a unilateral or bilateral capacity via a posterior or transforaminal lumbar interbody fusion interbody fusion approach, and may be used stand-alone, without supplemental fixation.
Bryan Wohlfeld, a neurosurgeon at the University of Texas Southwestern’s Zale-Lipshy University Hospital and the North Texas VA Medical Center, where he is chief of service for Neurological Surgery, comments, “The VariLift-LX System significantly expands the capability to use the technology in a true [minimally-invasive] approach.” He further comments that, “The new implant lengths and heights will allow surgeons to optimise use of the system for a larger portion of lumbar fusion patients.”
The VariLift-LX product release will increase the platform system to include eleven sizes, which is intended to provide surgeons with the flexibility to identify the optimal fit within the disc space, according to a company release.
In addition, new instrumentation has been designed to accomplish the distraction and retraction needs specific to minimally invasive surgery (MIS) procedures. The VariLift-LX design is consistent with Wenzel Spine’s core interbody device portfolio of expandable, grooved, and fluted titanium alloy fusion devices. The VariLift-LX has four large fenestrations and a generous bone graft chamber to promote vertebral fusion, according to Wenzel Spine.
Chad Neely, chief executive officer of Wenzel Spine, comments, “We are excited for the 510(k) clearance from the FDA for the new VariLift-LX system.” Neely adds, “We are also excited about the opportunities we have in 2016 to release new clinical data and initiate new clinical studies…”
VariLift-LX will be available in the USA through a limited release in the coming weeks. A full launch is planned in early spring 2016.