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ProTEX Med has undergone testing and characterization performed in resin, fibre and mesh forms, to demonstrate physical, chemical and biocompatibility equivalency.
15th April 2015
Innovation in Textiles
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Galway
Proxy Biomedical, a leading innovator in the design, development and manufacturing of biomaterials, has released its ProTEX Med Polypropylene Resin, a unique custom synthesized resin, available exclusively for Proxy Biomedical partners.
ProTEX Med can be provided as a textile component, assembly or finished device. Qualification of the device, for long-term implantation, is undertaken by the device owner themselves, with the assurance that the constituent material is not contra-indicated for long term human implantation.
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, fibre and mesh forms, to demonstrate physical, chemical and biocompatibility equivalency.
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, the company reports.
“There are serious concerns about companies implanting textiles that are not composed of materials sourced specifically for medical applications. The company aims to address these concerns with ProTEX Med polypropylene resin,” said Caitriona Conneely, QA & RA Manager, Proxy Biomedical.
“At Proxy Biomedical, we believe strongly in traceability, accountability, quality, consistency and safety of supply chain, from initial precursor substances to final materials production. ProTEX Med reduces the risks associated with a contraindicated resin, overcoming issues related to material regulatory compliance, while ensuring security and continuity of the supply chain.”
Proxy Biomedical has extensive expertise in homopolymers and compounds of both resorbable and non-resorbable materials, along with their respective characteristics, including mechanical performance, degradation profile, and biocompatibility.
Proxy Biomedical can also offer a custom synthesization service for partners looking for an exact match to specific polypropylene resin grades used in existing products. The service includes comprehensive testing and characterization, to demonstrate physical, chemical and biocompatibility equivalency, in resin, fibre and processed textile forms.
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