The FDA has granted 510k clearance to the Dyneema Purity Radiopaque Cerclage Cable made by DSM Biomedical. The cable is used by surgeons to treat bone and spine fractures.
Dutch Radiopaque Cables Earns FDA Clearance
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The cerclage cable is made out of Dyneema Purity Radiopaque fiber which, claims the manufacturer, is the only radiopaque ultra-high-molecular-weight polyethylene medical fiber in the world. According to DSM Biomedical, while there are currently other polymeric cerclage cables in the market, none are radiopaque and therefore cannot be visualized during and after surgical intervention.
DSM says that Dyneema Purity Radiopaque fiber is 15 times stronger than steel yet it is still pliable and flexible which, the company maintains, will lower the risk of bone damage. The fiber itself is biocompatible and chemically inert which, says DSM, can help reduce tissue inflammation, irritation and complications associated with metal allergies.
One of the key peculiarities of steel cables as fixation devices in trauma surgery is that the surgeon must guide both ends of the cable through a tensioning device. Once the surgeon has completed fixation with the steel cables, no incremental adjustments are possible. The surgeon can only re-adjust the steel cables by cutting those cables and starting all over again.
“Medical device manufacturers look to us for our development and engineering capabilities and our ability to deliver solutions that can assist them in getting their products to market quickly, ” said Carola Hansen, Director of Biomedical Polyethylenes, DSM Biomedical. “Not only does the FDA clearance facilitate our customers in the launch of their orthopedic trauma devices, it also strengthens the leadership position of Dyneema Purity fiber.”
“At Maastricht University Medical Center (The Netherlands), we have been studying the use of DSM’s Dyneema Purity Radiopaque fiber in cerclage cables as a replacement for metal surgical cables, ” said Lodewijk van Rijn, M.D., professor and head of the Orthopedic Surgery Department at MUMC. “This FDA clearance, which includes part of our research, will also support our ongoing studies on the development of innovative orthopedic treatment concepts.”
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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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