VertebralTechnologies, Inc. (VTI) has announced that 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.
VTI’s InterFuse Lateral Gets FDA 510(k)
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“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, in the September 19, 2013 news release. “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. According to the company, utilizing this method of intraoperative 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 InterFuseproducts allow for the optimal end plate coverage, customized to patient anatomy, and a smaller annulotomy, all while reducing nerve root traction and surgical exposure.
Dr. Felt told OTW, “Over the next 12 months, we plan to build out a complete inventory of InterFuse L sizes and make available to the surgeons several choices for medial/lateral (ML) and anterior/posterior (AP) dimensions, all in addition to commonly used heights. Given the modular design of our implant, this will allow the surgeon a unique ability to customize the implant to the patient’s anatomy. These features combined with the smaller access channel and annulotomy should be very appealing to spine surgeons who prefer the lateral approach.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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