The SAPIEN 3 transcatheter heart valve incorporates new design features, including an outer sealing cuff and a 14 Fr expandable sheath, intended to reduce paravalvular regurgitation and vascular injury.
Building on the established success with the SAPIEN, SAPIEN XT and earlier prototypic transcatheter heart valves (THV) the newest balloon-expandable valve incorporates a number of new and enhanced features intended to reduce the risk of vascular injury, to reduce paravalvular regurgitation, and to facilitate rapid and accurate positioning and implantation. The SAPIEN 3 THV incorporates a cobalt chromium stent, bovine pericardial leaflets, and both an inner and new outer polyethylene terephthalate sealing cuff. The delivery system incorporates an active three-dimensional coaxial positioning catheter, and is compatible with a 14 Fr expandable sheath.
Binder et al. (Sat,) studied this question.