Eragny-sur-Oise, France-based Safe Orthopaedics, a designer of single-use implants and instruments for minimally invasive spine surgeries, has announced the approval of its SteriSpineTM PS in Japan.
Single-Use Spine Implant Kit Approved in Japan
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SteriSpine PS is a kit for the treatment of spinal fractures and degenerative pathologies. The kit contains: a cannulated and fenestrated polyaxial screw, a MIS [minimally invasive surgery] fracture correction screw, a cross-connector that allows for top-loading insertion and tightening from the top, and an all-in-one non-toxic cement mixing kit that can fill up to six cannulas at the same time.
SteriSpine PS will be distributed by KiSCO Co., Ltd., Safe Orthopaedics’ exclusive partner for commercialization and distribution in Japan. Safe Orthopaedics and KiSCO entered into this partnership in June 2018. The agreement included a milestone payment in cash upon receipt of approval for SteriSpine PS.
Safe Orthopaedics is a French medical technology company that develops technologies to treat spinal fractures. Its sterile implants and disposable instruments are intended for minimally invasive surgeries. The Safe Orthopaedics SteriSpine kits are CE marked and FDA cleared.
Pierre Dumouchel, CEO and co-founder of Safe Orthopaedics, said, “The achievement of this milestone (approval of SteriSpine in Japan) is a great success for both companies and demonstrates the efficiency and close cooperation of the two teams. Now, the third largest Spine market in the world behind the United States and China, estimated to be worth $400 million, is ready to welcome Safe Orthopaedics’ products.”
KiSCO, established in 1968, became a member of the Otsuka group of companies in 2011. The company is “dedicated to the creation, development and sale of high-quality orthopedic medical devices.”
Ayumu Nakaji, CEO of KiSCO, said of the partnership, “KiSCO’s experienced sales teams have been trained on Safe Orthopaedics’ technology and are now ready to present it to surgeons and start selling in Japan.”
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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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