VICTREX
PEEK developed for spinal fusion implants receives approval in China
The material is already used in Europe and the US (Photo: Victrex) |
High performance plastics producer Victrex (Thornton Cleveleys / UK; www.victrex.com) has said its high-performance polymer for spinal fusion implants, “PEEK-Optima Ha Enhanced”, which enables early and direct bone apposition, has passed biocompatibility testing in China. Medical device manufacturers in Europe and the US are already offering implants based on the material, which is available from Invibio Biomaterial Solutions, the medical business of Victrex.
Biocompatibility testing of the material, which combines PEEK “Optima” and the osteoconductive material hydroxyapatite that helps the natural bone repair itself, has been successfully completed at the China Food and Drug Administration Tianjin medical device supervision and testing centre. The results are available in reports on delayed type hypersensitivity, skin irritation, genotoxicity, systematic toxicity, in-vitro cytotoxicity, sub-chronic toxicity and 26 week bone implantation. This final test is particularly significant because it will reduce the time involved in the application process when medical device manufacturers seek CFDA approval.
Biocompatibility testing of the material, which combines PEEK “Optima” and the osteoconductive material hydroxyapatite that helps the natural bone repair itself, has been successfully completed at the China Food and Drug Administration Tianjin medical device supervision and testing centre. The results are available in reports on delayed type hypersensitivity, skin irritation, genotoxicity, systematic toxicity, in-vitro cytotoxicity, sub-chronic toxicity and 26 week bone implantation. This final test is particularly significant because it will reduce the time involved in the application process when medical device manufacturers seek CFDA approval.
03.12.2015 Plasteurope.com [232803-0]
Published on 03.12.2015