Background and importance Cranioplasty implants have evolved considerably in recent years. Until 2019, Custom bone was the leader of the customised cranial implant market. Currently, a multitude of medical devices are available and the market for these implants is shared between several manufacturers. As implantable medical devices, these implants fall under pharmaceutical control in France. Because of their high cost, French regulations require a competition procedure to be launched.
Aim and objectives The purpose of this study was to provide an overview of the various refunded customised cranioplasty implants, so we can get highlight technical arguments to define the best procurement strategy in touch with the surgical team.
Material and methods We identified refunded implants in France using the national healthcare database. This first step was to identify all of the different manufacturers to contact them and obtain technical information. We then analysed and extracted information from the technical data sheet of the suppliers. We conducted a literature review of available implant use in cranioplasty (biomaterial composition and characteristics, production period, implant fixation method, cost). Twenty other university hospital centres were questioned to determine which implant was used most often. Finally, all of these data were synthetised in a comparative table.
Results We identified five refunded implants available on the French market and each had different characteristics (biomaterials, method of implantation). The results of this study showed that the Custom bone implant remained the most used at this time (9 of 20 university hospital centres). Furthermore, there were many comparative studies between synthetic implants and autologous bone. However, there were no comparative studies between different types of marketed implants.
Conclusion and relevance The lack of data made it difficult to objectively guide the choice of one implant over another. More comparative studies are needed to assess which method or biomaterial is better for the case study. This work showed that it is more appropriate to orient the purchasing strategy towards a multi beneficiary market. Thus the decision will be taken collectively with the neurosurgeons.
Conflict of interest No conflict of interest
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