Wenzel Spine, a provider of spinal fusion medical devices, has received US Food and Drug Administration (FDA) 510(k) clearance to market its VariLift expandable interbody fusion system for stand-alone use.
The VariLift interbody fusion system (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment.
The device is intended for the treatment of degenerative disc disease (DDD) at either one level or two contiguous levels, with up to Grade I spondylolisthesis.
Wenzel Spine CEO Chad Neely said that they are pleased that the FDA granted clearance to market the VariLift expandable interbody fusion system without the need for pedicle screws and acts as a lumbar fusion option for spine surgeons to offer to their patients.
“Proven stand-alone solutions like VariLift that don’t require supplemental fixation are essential for surgeons and patients currently and it is one of the original zero-profile spine implants, a design philosophy that has gained favor of late. Its expansion feature, in particular, has allowed it to garner outstanding clinical results over the last 10 years in thousands of patients,” Neely said.