ProTEX Med™ Implantable Grade Polypropylene Resin
Aran Biomedical’s proprietary medical grade Polypropylene (PP) – ProTEX Med™, is a custom synthesised resin, exclusively available for partners leveraging downstream textile conversion processes. It is certified to technical specifications and ISO 10993-5 (cytotoxicity), with proven equivalency to currently implanted PP grades. ProTEX Med™ comes with a unique FDA Device Master File reference, available to resin users to support associated product qualification.
Users of ProTEX Med are assured that constituent material of their implantable devices, is not contraindicated for long term human implantation. Therefore, product specific qualification of the device for long-term implantation, undertaken by the device owner, will determine device fitness for use.
What are the benefits of using our proprietary polypropylene resin?
Benefits of Our Medical Grade Polypropylene Resin
Aran Biomedical also offer a custom synthesis service for partners looking for an exact match to specific polypropylene resin grades used in existing products. The service includes comprehensive testing and characterisation to demonstrate physical, chemical and biocompatibility equivalency, in resin, fibre and processed textile forms. This approach addresses material regulatory compliance for existing products, while ensuring long term security of supply. ProtexMED, has already been cleared by the FDA, for a surgical implant application. Namely our own VitaMESH Hernia Mesh product.
ProTEX Med Case Study
Learn how a leading medical device company leveraged our proprietary ProTEX Med to overcome it’s supply challenges.