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Admin Feb 23, 2019 12:00:00 AM 1 min read

Wenzel Spine Announces FDA Clearance to Include Allograft with the VariLift® Product Family

We are pleased to have recently received clearance from the U.S. Food and Drug Administration (FDA) to market our Expandable Stand-Alone VariLift® systems for use with allograft.

Wenzel Spine’s VariLift® Platforms Now Provide the Broadest Clearance of an Expandable Interbody Fusion Device on the Market.

When expanded, the large fenestrations of our VariLift® devices allow for maximum bone to graft contact as well as overpacking the disc space with graft material post implantation and expansion. This new FDA clearance will give surgeons more options in sourcing the graft tissue that meets their patients specific needs. Check out the video below to see the VariLift®-LX graft chamber in action.

VariLift® System Expands Indications

VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

VariLift®-C is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

If you would like more information about VariLift® and the benefits of our expandable standalone devices, send us a message and we'll set up a call with one of our sales managers. We look forward to connecting with you soon.