Mechanical Properties of Polyamide 12 for the use in Balloon-Expandable Transcatheter Heart Valves

The SAPIEN 3 Ultra transcatheter heart valve (THV) is implanted in the stenotic aortic valve using an expandable balloon. This study aims to characterize the mechanical behaviour of balloon-related polyamide 12 (PA12) under uniaxial tensile testing at controlled temperatures as well as the viscoplastic response. Three-dimensional (3D) digital image correlation (DIC) was also carried out to determine the strain distribution of the whole device. Data were used to develop a material constitutive model for finite-element analysis. Findings demonstrated the complex mechanical behaviour of PA12 used in balloon catheter, suggesting the need for accurate constitutive modelling.