Texas-based medical device company SpineSmith landed FDA approval for its VisuALIF challenging access plate system, which could provide surgeons an additional surgical approach option for in-situ graft delivery and a more appropriate plate system for handling anatomical challenges.
The company said the VisuALIF system offers alternatives to the traditional devices, which feature a 2-screw, zero-profile fixation, and its open access allows physicians to visualize the disc space for in-situ implant preparation.
"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,” CEO Kevin Dunworth said in prepared remarks. “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."
SpineSmith Partners in October 2010 announced FDA clearance for its VisuALIF interbody fusion implant system, launching the product during the North American Spine Society’s annual meeting in Orlando, Fla.
SpineSmith plans to introduce its VisuALIF Challenging Access System at the North American Spine Society meeting, which takes place in Dallas, Texas this week.
