Medical implants company Proxy Biomedical (Coilleach, Co Galway / Ireland; www.proxybiomedical.com) has launched a PP resin for implantable medical devices. The new resin, “Protex Med”, is suitable for long-term implantation and can be provided as a textile component, sub-assembly or finished device. It is certified to technical specifications and ISO 10993-5 (cytotoxicity), with proven equivalency to currently implanted PP grades, the company said. A file registration for Protex Med is in place, with a US FDA Device Master File reference available to resin users in support of associated product qualification.

Caitriona Conneely, quality assurance and regulatory affairs manager at Proxy Biomedical, said the company launched the material to address concerns about the implanting of textiles that are not composed of materials sourced specifically for medical applications. “At Proxy Biomedical, we believe strongly in traceability, accountability, quality, consistency and safety of supply chain, from initial precursor substances to final implant production,” she stated. “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.”