SpineSmith Partners, a Texas-based medical device company, has received US Food and Drug Administration (FDA) clearance for commercial sale of its VisuALIF interbody fusion implant system in the US.
The VisuALIF is a two-piece, stand alone device indicated for intervertebral body fusion of the lumbar spine.
SpineSmith claims that VisuALIF is the first modular lumbar interbody device with an open-face allowing in situ graft placement, tactile feedback with face plate attachment and device placement flush with the anterior aspect of the vertebrae.
The device is available in a range of product sizes and configurations designed to meet surgeon requirements across a wide spectrum of patient anatomy, SpineSmith said.
SpineSmith’s general partner Kevin Dunworth said that the VisuALIF will offer a unique solution for surgeons and the VisuALIF incorporates an anterior open-face allowing surgeons to visualise disc and end plate preparation leading to optimum graft placement with respect to available volume.