Biomaterials developer Proxy Biomedical (Galway, Ireland) announced today the release of ProTEX Med polypropylene (PP) resin, a custom synthesized resin for medical implantable use. The material is available exclusively for Proxy Biomedical partners, and can be provided as a textile component, subassembly or finished device.
ProTEX Med is certified to technical specifications and ISO 10993-5 (cytotoxicity), with proven equivalency to currently implanted polypropylene grades. The material has undergone comprehensive testing and characterization performed in resin, fiber and mesh forms to demonstrate physical, chemical and biocompatibility equivalency, according to Proxy Biomedical. A file registration for ProTEX Med is in place, with a unique FDA Device Master File reference, available to resin users in support of associated product qualification.