Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 20, 2011, from 8 a.m. to 6 p.m (Day 1 of 2)]

Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper