A minimally invasive lumbar surgery system, called the TowerLOX, developed by Captiva Spine, Inc., has received 510(k) clearance from the FDA. Developers describe the device as a “cannulated pedicle screw, tower and rod delivery system.” They say that TowerLOX provides a reliable rod insertion method by “controlling the angle of the spinal rod to optimize the insertion approach required for rod delivery into each pedicle screw.”
TowerLOX Awarded FDA 510(k) Clearance
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“The FDA clearance of this new system is an important milestone for Captiva Spine, ” said Dale Mitchell, company president and founder. “This system clearly demonstrates our ability to provide innovative solutions through collaboration with industry experts, surgeons, and Captiva’s quality and engineering team.”
Founded in 2007, Captiva Spine is a privately owned medical devices organization headquartered in Jupiter, Florida. The company markets fusion technologies in the U.S. and internationally.
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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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