Abstract
The Thoratec® Ventricular Assist Device (VAD) System utilizes Thoralon® for the blood pumping sac and inflow and outflow cannulas. Thoralon is a polyetherurethaneurea (PEUU) blended with a siloxane-based surface modifying additive. The purpose of this study is to perform a physicochemical evaluation of VAD blood sacs explanted from human subjects. Four blood sacs were analyzed after 53, 171, 336 and 434 days of use and compared to unimplanted controls. Tensile strength, 300% stres and Young's modulus of explanted blood sacs showed slight increases over the controls, whereas % elongation showed slight decrease. Both number average and weight average molecular weight were higher than the unimplanted control. However, the duration of implantation had no significant effect.TableThere was no difference observed in the physical properties and molecular weight between high and low flex regions of the blood sacs. SEM and ATR FT-IR analysis did not show any signs of surface degradation. The results support the long-term biodurability of Thoralon for use in ventricular assist device clinical applications.
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