Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 13, 2012 8:00 a.m. - 6:00 p.m.

Agenda: On June 13, 2012, 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 SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.

The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories implant system consists of the following:
• A heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in two 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.