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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.