VariLift-LX represents the next generation of Wenzel Spine’s innovative product lines of zero-profile, stand-alone, expandable interbody fusion devices. Like the full line of VariLift lumbar devices, VariLift-LX is indicated to be implanted in a unilateral or bilateral capacity via a PLIF or TLIF approach and may be used stand-alone, without supplemental fixation, according to the company.
“VariLift is an outstanding option for spine surgeons performing lumbar fusion surgery as it simplifies interbody fusion procedures by eliminating the need for supplemental fixation. The VariLift-LX System significantly expands the capability to use the technology in a true MIS approach,” said Dr. Bryan Wohlfeld, a neurosurgeon at 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. “The new implant lengths and heights will allow surgeons to optimize use of the system for a larger portion of lumbar fusion patients.”
The VariLift-LX product release will increase the platform system to include 11 sizes, providing surgeons with the flexibility to identify the optimal fit within the disc space. In addition, new instrumentation has been designed to accomplish the distraction and retraction needs specific to 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. All Wenzel Spine VariLift devices are designed with the benefit to surgeons of simplified and shortened spine fusion surgery, while providing excellent clinical outcomes for patients.
“We are excited for the 510(k) clearance from the FDA for the new VariLift-LX System. This expansion of the VariLift System represents a significant step forward in our stand-alone interbody technology," said Chad Neely, CEO of Wenzel Spine. "Our team is looking forward to initiating the limited release in coming weeks, and wide release of the new system this spring. We are also excited about the opportunities we have in 2016 to release new clinical data and initiate new clinical studies that demonstrate the excellent clinical outcomes across the country that surgeons are achieving with use of the VariLift technology.”
VariLift-LX will be available in the United States through a limited release in the next few weeks. A full launch is planned in early spring.
Wenzel Spine is an Austin, Texas-based developer of interbody spinal fusion devices.