17 September 2006
17 September 2006
Invibio this week launched Endolign composite, a new biocompatible carbon fibre-reinforced thermoplastic material for use in implantable load bearing medical device applications requiring blood, bone or tissue contact of more than 30 days.
The Endolign composite and process offer the high strength of metals combined with the extensive biocompatibility and imaging compatibility of polymers. Biocompatibility testing of Endolign composite confirms that it exceeds the requirements of ISO 10993 standards for long-term implantable medical devices.
Endolign is manufactured by combining high levels of continuous carbon fibres with PEEK in the form of a pre-impregnated tape which can then be moulded into rods or other forms. Because it is radiolucent, Endolign enables visualization through imaging techniques such as X-ray and Computer Tomography (CT) and being non-metallic, Invibio say that the material is compatible with MRI.
“Endolign composite will enable medical device manufacturers to develop a new generation of implants with better imaging characteristics and improved strength,” said Michael Callahan, president of Invibio. “Because of its outstanding properties, Endolign is ideally suited for the development of long-term implantable load bearing medical device applications.”
Invibio’s Endolign composite is currently provided as a pre-preg tape for conventional high performance thermoplastic composite processing by compression moulding, autoclave moulding, filament winding or pultrusion, or as custom-made pre-formed unidirectionally reinforced rods. Parts can also be fabricated using the novel method of composite flow moulding (CFM) by Icotec for which there are CE marked and FDA cleared devices.
Endolign composite is currently used in the development of load bearing applications including spinal fixation devices like translaminar fixation pins, spinal fusion cages and in trauma devices such as bone fracture plates, screws and intermedullary nails.