SpineVision, headquartered in Antony, France, has announced that it has received the CE mark for its next-generation Pivot Link Universal System (P.L.U.S.) spine deformity-correction system. SpineVision introduced the system to the 2018 EuroSpine meeting and 2018 North American Spine Society annual meeting in Los Angeles.
SpineVision: CE Mark for Next-Gen P.L.U.S. Spinal System
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“The introduction of our Pivot Link Universal System (P.L.U.S.) extends our successful track record of commercializing cutting-edge products encompassing all spine pathologies,” said Arnaud Brisard, CEO of SpineVision. “We believe that this next generation of an already successful product will be enthusiastically embraced by orthopedic surgeons, because the P.L.U.S. is designed to make every step of spine deformity surgery more facile for the orthopedic surgeon—especially correction maneuvers before final locking.”
“The P.L.U.S. Pivot Link Universal System features and benefits include:
- A narrow 11.5mm-wide implant and a 6.0mm-diameter rod for a strong, low-profile construct;
- An innovative “clip” technology with an implant-to-bone interface for hooks or screws that surgeons may use during correction maneuvers before final locking;
- A “pivot link” that angulates with the rod in the sagittal plane to adjust to spinal anatomy before final locking;
- A novel low profile (clip system instead of high screw-heads) enabling more flexibility during surgery;
- An unmatched freedom of the screw-head: 180-degree transverse / 50-degree sagittal angulation.”
Arnaud Brisard commented to OTW, “This is a premium system with high-quality instrumentation using a clip technology that simultaneously permits very low-profile implants and safety when performing complex corrections.”
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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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