510(k) Clearance for Modular Lateral Interbody Spinal Fusion Device
InterFuse L™ alpha launch expected late 2013.
Vertebral Technologies, Inc. (VTI) is pleased to announce the InterFuse Lateral (InterFuse L™) a modular lateral lumbar interbody fusion device has received 510(k) clearance from the FDA. The InterFuse L™ uses VTI’s patented modular insertion technique to provide a large lateral footprint through a significantly smaller lateral access channel. The InterFuse L™ alpha launch is scheduled for mid-November.
“The InterFuse® Lateral modular implant allows the surgeon to obtain the maximal footprint across the end plates allowing an access channel that can be as much as one half the size required for other Lateral implants,” said Jeffrey C. Felt M.D., Chairman and CEO of VTI. “This will result in much less traction being placed on the nerves of the lateral plexus and, thus, fewer patients with post-op symptoms related to nerve root irritation.”
The InterFuse L™ is implanted through a lateral approach and assembled in the disc space using a proprietary rail and slot technology. Utilizing this method of intraopertive assembly allows for a less-invasive approach while providing the maximum lateral footprint. The InterFuse L™ is designed to expedite patient recovery, decrease the risk of subsidence and migration, and increase the percentage of successful fusions.
Recognizing the need for less-invasive surgical technology, VTI has developed a modular fusion device for each of the four common approaches and has obtained FDA clearance for each of them. The InterFuse® products allow for the optimal end plate coverage, customized to patient anatomy, and a smaller annulotomny, all while reducing nerve root traction and surgical exposure.
About Vertebral Technologies, Inc.
Headquartered in Minneapolis, Vertebral Technologies, Inc. (VTI) is the leading developer of intra-operative assembly™ technology. Founded in 2008, VTI is committed to addressing painful conditions in the spine by its continued advancement in designing, developing and manufacturing medical devices that provide full end plate coverage with less invasive surgical approaches.
For more information visit, http://www.vti-spine.com