ProTEX Med® Implantable Grade Polypropylene Resin
Aran Biomedical’s proprietary medical grade Polypropylene (PP) – ProTEX Med®, is a custom synthesised resin, available for partners leveraging downstream textile conversion processes or as a standalone material for medical applications. 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.