| Dr. Paul E. Labossiere1 and Dr. Kenneth E. Perry2, 1ECHOBIO, LLC., 579 Azalea Avenue, Bainbridge Island, WA 98110, 2Echobio, LLC, 579 Azalea Avenue, Bainbridge Island, WA 98110
An overview of the typical in vitro test methods used to characterize the performance of Nitinol stents is presented. This necessitates a consitent definition and understanding of radial force as well as a consideration of the sensitivity of the various methods to friction, fixture compliance, material uncertainty and other experimental factors. These sensitivities are demonstrated using finite element analysis and in vitro experimentation. The results help guide the development of better experimental methodologies and interpretation of performance parameters such as radial force. Finally we conclude with recommendations for establishing a rigorous, self-consistent approach to Nitinol component design, testing and validation. |