DSM Biomedical, a global leader in biomedical materials science and regenerative medicine, announced that the U.S. Food and Drug Administration (FDA) has cleared the Dyneema Purity® Radiopaque Cerclage Cable for use in orthopedic trauma treatments, such as treatment of bone and spine fractures.
The Dyneema Purity® Radiopaque Cerclage Cable, the first device fully designed and developed by DSM’s Biomedical Polyethylenes Team to receive 510k clearance from the FDA, marks a milestone for the company. DSM sought 510k clearance to support DSM’s customers in bringing their medical devices for use in orthopedic trauma to market.
The cerclage cable is made out of Dyneema Purity® Radiopaque fiber, the only radiopaque ultra-high-molecular-weight polyethylene (UHMWPE) medical fiber in the world. While there are currently other polymeric cerclage cables in the market, these are not radiopaque and therefore cannot be visualized during and after surgical intervention. Dyneema Purity® Radiopaque fiber is 15 times stronger than steel while maintaining high pliability and increased flexibility, which may help lower the risk of bone damage. The fiber is biocompatible and chemically inert, which can help reduce tissue inflammation, irritation and complications associated with metal allergies. When using steel cables, both ends of the cable must be guided through a tensioning device, and once fixation is complete, no incremental adjustments are possible. Re-adjustment can only be accomplished by cutting the cable 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."
DSM Biomedical leveraged its vast experience in developing UHMWPE medical fibers as well as its participation in a public-private partnership with Maastricht University Medical Center (The Netherlands) to design this new concept in cerclage cable.
"At MUMC, we have been studying the use of DSM’s Dyneema Purity® Radiopaque fiber in cerclage cables as a replacement for metal surgical cables," said Dr. Lodewijk van Rijn, professor and head of 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."