Kleiner Device Labs, based in Incline Village, Nevada, has been honored with the 2022 Medical Design Excellence Awards (Implant and Tissue-Replacement Products category) for its new KG2 Surge flow-thru interbody system.
Kleiner Device Labs Wins 2022 Med Design Excellence Award
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Medical Design Excellence Awards are geared toward “life-saving innovations and remarkable technological advancements. The Medical Design Excellence Awards are determined each year by an independent panel—clinicians, engineers and designers—to select finalists as well as winners in each of 10 product categories.”
“We are proud to earn this recognition of the many years of work and innovation that have gone into developing the company’s unique flow-thru technology that is key to the new KG2 interbody system and our future product pipeline,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.
Delving into the maximizing of total bone graft delivery volume, Dr. Kleiner told OTW, “There are a couple of vital steps necessary to maximize bone graft delivery volume. First of all, attention must be directed to preparing the disc space. As much disc material as possible must be removed to create room for the bone graft. Next, using the appropriate graft delivery device is key to filling the entire space.”
“Conventional, round, end-dispensing cannulas apply the graft directly in the path of the device, fill from the bottom up, and do not distribute the graft to either side of the device; incomplete filling of the prepared area is the result.”
“A bi-portal graft extrusion system with an internal ramp within the cannula or implant is unique to the KG system and this works to direct the graft to either side of the device, allowing complete, side-to-side filling of the disc space.”
Regarding the improved distribution of graft bilaterally into the intervertebral disc space, he added, “The KG system is specifically designed to maximize the volume of graft delivered by having a ramp within the cannula or implant that allows a directed, bi-portal exit of graft material into the prepared disc space.”
“The graft naturally takes the path of least resistance and completely fills the disc space on either side of the apparatus. The interbody implant serves as a conduit through which graft material flows into the prepared disc space in the optimal distracted position.”
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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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