GALWAY, Ireland — April 14, 2015 — Proxy Biomedical, a leading global innovator in the design, development and manufacturing of biomaterials, today announced the release of ProTEX Med™ Polypropylene Resin, a unique custom synthesized resin, available exclusively for Proxy Biomedical partners, leveraging downstream textile conversion processes. ProTEX Med can be provided as a textile component, sub‐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, fiber 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.
“There are serious concerns about companies implanting textiles that are not composed of materials sourced specifically for medical applications; Proxy Biomedical 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, fiber and processed textile forms. This approach addresses material regulatory compliance for existing products, while ensuring long term security of supply.
Posted April 14, 2015
Source: Proxy Biomedical