FDA approves VisuALIF Challenging Access Plate


The US Food and Drug Administration (FDA) has approved the VisuALIF Challenging Access Plate System (SpineSmith). The plating system provides surgeons with additional surgical approach options for difficult anatomical angles and allows for fixation beyond the two screws, zero profile plate currently being offered.  

The Challenging Access System is a plating extension to the VisuALIF system, which is designed to give surgeons the option for in-situ graft delivery and provide the ability to choose the appropriate plate system depending on different anatomical challenges. The Challenging Access Plate is implanted via an open anterior approach and provides ease of use when approaching the challenges at the L5–S1 juncture. VisuALIF’s open access allows a physician to visualise the disc space for in-situ implant preparation, prepare for optimal end plate contact and maximise a large volume of graft.

“Our core competency is building cell-centric devices giving surgeons the opportunity to optimise graft and regenerative cells delivery to achieve fusion in the lumbar spine. We believe the VisuALIF system provides surgeons a complete system to take advantage of an anterior open access to recreate the biological environment necessary for fusion as well as fixation solutions that provide the stability necessary to achieve successful clinical outcomes,” said Kevin Dunworth, CEO of SpineSmith.