The U.S. patent office has just awarded patent # US20230255791A1 for a novel spine fusion system which, after the first 50 cases, took surgeons an average of only 8 minutes to trial, implant, graft and release the lumbar interbody device with the KG™2 Surge system, and that both the mean and median volume of graft delivered was 10ml.
Patent Issued for Novel 8-Minute Spine Fusion System
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The implant system, brand named KG™2 Surge system is manufactured by Nevada-based Kleiner Device Labs.
Founder and CEO Jeff Kleiner, M.D. said, “We set out from the beginning to create answers for surgeons to maximize spinal fusion bone graft delivery and solve many of the most frustrating parts of spinal fusion procedures that negatively impact both the patient and the surgeon.”
“The technology that we developed with the KG™2 Surge system simplifies the post-insertion delivery of a wide range of graft materials through the interbody and into the surrounding disc space,” added CTO Alan Burkholder. “Surgeons have successfully delivered milled local autograft, cortical cancellous chips, long-fiber allografts, and DBM putties.”
Kleiner’s design is the marriage of a rectangular inserter tube with a 3-D printed titanium interbody with a large matching opening and a bifurcated ramp that distributes the graft bilaterally. According to the company, that unique design allows surgeons to fill both the cage and the surrounding disc space.
The KG™2 Surge flow-thru interbody system was developed by Kleiner to maximize bone graft delivery to the prepared intervertebral disc space, and thereby streamline implant placement, positioning, and integration in the graft matrix.
Kleiner is offering a summary of the first 50 case results if you reach out to the company and ask for it.
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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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