Medical device manufacturers looking to innovate and differentiate trauma products while delivering clinical benefits can capitalise on a new technology platform. The offering from Invibio Biomaterial Solutions delivers trauma plates composed of their high-performance composite, Peek-Optima Ultra Reinforced. Clear regulatory device predicates in the US and Europe enable medical device manufacturers to more easily expand their trauma range beyond metal technologies. The polymer-based anatomic devices could be appropriate in those cases, where the prognosis is poor, particularly with high risk patients.
Price pressure and margin erosion are forcing medical device manufacturers to explore the development of new trauma solutions that continue to help to improve patients’ clinical outcomes. For medical device manufacturers, Invibio can add significant value with respect to design, manufacturing and materials knowledge, reducing the investment of time and money typically associated with significant innovation.
Peek-Optima Ultra Reinforced improves the visibility of the fracture during surgery, improving the ability to assess reduction and alignment. Initial results from an ongoing survey indicate that over 80% of surgeons can identify poor fracture alignment when Peek-Optima Ultra Reinforced is used as opposed to less than 30% for metals. The survey is focused on the assessment of two fracture fixation areas, the proximal humerus and the distal femur.
Peek-Optima Ultra Reinforced combines the high-performance material properties of natural polymers with the additional strength imparted by continuous carbon fibre. The material can be tailored to have mechanical strength similar to that of metallic plates, combined with a 50X greater resistance to fatigue, extending implant lifetime. Hardware removal complications are likely to be reduced as carbon fibre composites are biologically inert, having low tissue adhesion and cold welding of screws does not occur. Invibio is leveraging its Peek polymer-based medical composites manufacturing capability, along with its significant R&D resources, to provide a total solution for designers and manufacturers of implantable devices used for the fixation of fractures.
