Globus Medical, Inc. says it has launched the first expandable spacer on the market to offer the benefits of a traditional anterior implant, without a two-part disruptive surgical procedure.
Globus Claims First With Spine Spacer
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The LATIS implant is a minimally invasive (MIS) lumber interbody fusion spacer.
The implant, for patients with degenerative disc disease (DDD), is inserted through an MIS TLIF (transforaminal lumbar interbody fusion) approach and expands laterally. The company said the spacer provides a footprint and graft volume equivalent to an ALIF (anterior lumbar interbody fusion spacer) or LLIF (lateral lumbar interbody fusion) spacer.
In addition, the company says the spacer does not require anterior access or nerve monitoring, and allows for direct decompression of nerve roots via the MIS TLIF approach. “The 10mm-wide titanium implant can be inserted posteriorly and can expand in-situ up to 26mm square, offering the largest single bone graft chamber for any posterior implant on the market. Designed to reduce subsidence and migration, the spacer has a locking set screw that secures deployment at any position within the expansion range, ” stated the June 20, 2013, company press release.
The spacer has a locking set screw that secures deployment at any position within the expansion range and is designed to reduce subsidence and migration.
“Combined with posterior stabilization using our Revolve MIS pedicle screw system, the entire procedure is designed and intended to maximize preservation of the stabilizing muscles of the lower back, ” said the company’s Senior Vice President of Global Product Development Andrew Iott.
According to the company, the spacer is “intended for use in patients with DDD at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).” Spacers are to be filled with autogenous bone graft material and used with supplemental fixation.
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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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