September 1, 2012
View Full PaperEdwards SAPIEN 3 valve
Structured PICO
I
Intervention
Edwards SAPIEN 3 transcatheter heart valve
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.
Abstract
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.