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Composite trauma device technology for internal fracture fixation

News International-French

22 Oct 2014

Invibio Biomaterial Solutions developed trauma plates with 50x greater fatigue resistance compared to metal options and cost-saving potential for healthcare providers.

Trauma plates composed of a high performance polymer provide patients at risk of complications with a greater window for healing compared to metallic plates. The trauma device technology is based on a composite called “PEEK-OPTIMA Ultra Reinforced polymer”. It delivers similar mechanical strength to metallic plates, with 50x greater fatigue resistance.

Delayed or non-unions cost healthcare providers more than $2 billion in failed operations in the US alone. Non-union rates in the literature have been detailed as high as 18% for distal femur plating. Despite this and the fact that patients risk profiles for non-unions vary enormously there are very limited material options for treating patients.

High risk patients: Enhanced healing potential saves costs
“Patients who are at risk for slow or delayed healing can benefit from implants composed of PEEK-OPTIMA Ultra-Reinforced because the fatigue life is so much greater than metal. They’re more likely to be able to heal their fracture before their implant fails due to fatigue. There’s a whole host of patients that are slow to heal, including smokers and patients with diabetes, poor bone quality or open fractures, who have an enhanced potential to heal,” states David J. Hak, MD, MBA, Orthopaedic Surgeon at Denver Health, University of Colorado.

Rapid market entry saves device manufactures time and costs
Invibio Trauma Device Technology is a platform that allows medical device manufacturers to quickly design, validate and manufacture semi-rigid anatomic plates composed of PEEK-OPTIMA Ultra Reinforced polymer.

The polymer is a composite of PEEK Natural polymer reinforced with continuous carbon fibers, provides the strength and fatigue resistance demanded by high-load trauma implant applications. Using this polymer, designers can alter stiffness and develop trauma implants that are less rigid than metal implants, increasing dynamic loading and promoting secondary healing at the fracture site. This Invibio Trauma Device Technology gives surgeons a new option for treating patients at high risk of developing complications related to internal trauma fixation, such as non-unions, delayed unions and implant failures.

Surgeons gain insight during reduction and throughout the healing process
The imaging characteristics of this material give surgeons the ability to see the fracture site from all angles under x-ray. During the procedure, this can ease reduction and ensure proper alignment for healing to occur. After the procedure, it offers greater visibility of the fracture healing site so that surgeons can make more informed decisions about when to return patients to load-bearing activities.

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