ATX West, MD&M West, Plastec West, West Pack, and Design & Manufacturing West is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Is my Nitinol Device Safe? Testing Strategies for Nickel Rich Medical Devices

Joe Grappin (Technical Business Development Executive, EAG Laboratories - Eurofins Materials Science Division)

Location: Tech Theater, Booth 637, Hall E

Date: Tuesday, February 5

Time: 11:30am - 12:15pm

Track: Tech Theater

Vault Recording: TBD

Audience Level: All

Shape memory materials have revolutionized the therapies in the cardiovascular and neurovascular spaces with their unique ability to compress and expand back into their original shape set upon deployment. These shape memory materials are generally nickel-titanium alloys, i.e. Nitinol, which when processed and handled correctly have been proven to be structurally durable as well as biocompatible. However, the processing of these alloys, if not controlled, could result in corrosion and premature failure as well as allow excess amounts of nickel ion to release. This in turn could impact the biological safety of the device. This talk will discuss the analytical testing strategies available to show that the manufacturing processing of these materials is at a validated steady state and how the analytical tests meet the guidance requirements of FDA and the EU MDR.