FDA Clears Vertebral Technologies’ Less Invasive Lumbar Fusion System

Vertebral Technologies, Inc. has gained FDA 510(k) Clearance for its InterFuse Lateral (InterFuse L™) device and plans to launch it in November. The InterFuse L™, a modular lateral lumbar interbody fusion device, uses VTI’s patented modular insertion technique to provide a large lateral footprint through a significantly smaller lateral access channel.

Background

Vertebral Technologies is the leading developer of what it calls intra-operative assembly™ technology. The company’s mission is to address painful conditions in the spine by advancing design, development and manufacturing of medical devices that provide full end plate coverage with less invasive surgical approaches.

True to the cause, InterFuse L™ is implanted through a lateral approach and assembled in the disc space using a proprietary rail and slot technology. This method allows for a less-invasive approach while providing the maximum lateral footprint. VTI says InterFuse L™ is designed to expedite patient recovery, decrease the risk of subsidence and migration, and increase the percentage of successful fusions.

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 annulotomy, all while reducing nerve root traction and surgical exposure.

Company comments

“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.”

Source: Vertebral technologies, Inc., PR Web