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FDA approves challenging access plate system from SpineSmith
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SpineSmith announced the FDA approval of the VisuALIF Challenging Access Plate System, which 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.
A plating extension to the VisuALIF system, the challenging access system is implanted via an open anterior approach and provides ease of use when approaching the challenges at the L5-S1 juncture, according to a press release.
The system 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. VisuALIF also allows physicians to visualize the disc space for in situ implant preparation through open access, prepare for optimal end plate contact and maximize a large volume of graft.
“Our core competency is building cell-centric devices giving surgeons the opportunity to optimize 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 outcome,” Kevin Dunworth, CEO of SpineSmith, stated in a press release.