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

  • Streamline your supply chain (resin-fibre-textile solution)
  • Ensure continuity of material supply for your medical implants
  • End-to-End solutions for implantable biomaterials product design, development and manufacturing services in a class 8 cleanroom environment
  • FDA 21 CFR 820/ ISO 13485:2012 Quality Management System
  • Regulatory consultation supporting product qualification
  • Reduce the risk associated with a contra-indicated resin
  • Custom polypropylene synthesis available on request

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.

Click Here to Download our ProTEX Med™ One-Pager

ProTEX Med Case Study

Learn how a leading medical device company leveraged our proprietary ProTEX Med to overcome it’s supply challenges.