SpineSmith Announces FDA Approval for VisuALIF Challenging Access Plate
AUSTIN, Texas, Oct. 23, 2012 /PRNewswire/ -- SpineSmith announces the U.S. Food and Drug Administration's approval of the VisuALIF® Challenging Access Plate System. 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 visualize the disc space for in-situ implant preparation, 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 outcomes," said Kevin Dunworth, CEO of SpineSmith.
SpineSmith will debut the VisuALIF® Challenging Access System at the North American Spine Society meeting in Dallas October 24 – 27th.
About SpineSmith LLC- A Celling Biosciences Company
SpineSmith Partners LP designs, develops and markets implants and biologics for surgical fixation, correction and tissue regeneration of the spine. SpineSmith utilizes a collaborative approach between scientists, engineers and spine surgeons. Our unique approach gives spine surgeons the ability to directly impact the direction of our product portfolio, ensuring applicability and achieving the highest standards of patient care. For more information please visit: www.spinesmithusa.com.
About Celling Biosciences
Celling Biosciences, works closely with surgeons, scientists and engineers to research and develop innovative technologies in the emerging field of regenerative medicine. Celling's product-offering focuses on autologous adult stem cell therapy and the devices and services that compliment these procedures. For more information please visit: www.cellingbiosciences.com.