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Thursday, August 26, 2004 - 8:30 AM
SES 4A.1

Lead Presentation: Potential Defects Associated with Nitinol Stents Manufactured by Laser Micro Machining

M. H. Wu, Edwards Lifesciences, Irvine, CA; S. Carpenter, P. H. Adler, R. Stevens, S. Herreria, Memry Coporation, Bethel, CT; D. Lowe, Abbott Laboratory, Redwood City, CA

Self-expanding peripheral stents are generally manufactured by laser cutting of superelastic Nitinol tubing. The laser-cut preforms are mechanically expanded and heat-treated to shape. Surface imperfections are removed by mechanical polishing or blasting, and then by electropolishing to achieve a high quality, smooth surface finish. The stents are finally passivated to enhance corrosion resistance. Various types of defects may originate from imperfections in the tubing and along these fabrication processes, which may degrade the corrosion resistance, fatigue endurance and even mechanical integrity of the final product. The present paper reviews examples of these defects. The likely causes and implications of the defects as well as related issues of process control are discussed.