Immersion testing of medical implants is typically performed under non-loaded conditions to assess susceptibility of metal ion release from a device. However, many implants are subjected to repetitive forces in vivo, which may increase ion release into surrounding tissues. Therefore, the objective of this study was to determine whether fatigue loading of stents with different surface finishes accelerates nickel release. Nitinol stents with an electropolished (EP) oxide or blue oxide (BO) were assigned to the following groups: (1) static immersion without loading, (2) static fluid pressure and bend, (3) dynamic pressure on a static bend, and (4) dynamic bending with static pressure. Immersion fluid was collected periodically and analyzed for nickel concentration using ICP-MS. Results indicated nickel release under dynamic bending was greater by up to 280× for EP and 190× for BO finishes compared to all other groups (p < 0.02). Although not significant (p > 0.27), nickel release under dynamic pressure conditions was up to 50× higher compared to static groups. In addition, BO stents released up to 6× greater levels of nickel compared to EP stents for static immersion, dynamic pressure, and dynamic bending groups (p < 0.05). These findings highlight the impact of fatigue loading on uniform corrosion for different nitinol stent surfaces.
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This study was made possible through research collaborative agreements between FDA and Medical Device Testing (now Element Materials Technology Corporation) and G. Rau Inc. The authors would like to thank FDA researchers Shiril Sivan and Stacey Sullivan for technical assistance and David Saylor for manuscript review. The authors would like to acknowledge the FDA White Oak Nanotechnology Core Facility for instrument use, scientific and technical assistance. The findings and conclusions in this paper have not been formally disseminated by the Food and Drug Administration, are the views of the authors, and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Department of Health and Human Services.
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Nagaraja, S., Chandrasekar, V., Ormonde, D. et al. The Impact of Fatigue Testing and Surface Processing on Nickel Release in Nitinol Stents. Shap. Mem. Superelasticity 4, 462–471 (2018). https://doi.org/10.1007/s40830-018-00196-0
- Cardiovascular stents
- Nickel release
- Surface processing