A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Methods of implanting prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, a compressible and expandable prosthetic heart valve includes a support stent comprising an expandable tubular base and three upstanding commissure posts. The three commissure posts are spaced at 120 degree intervals. The prosthetic heart valve further includes a tubular flexible member which is secured to the support stent. The tubular flexible member preferably includes a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets and three commissure portions. The commissure portions are secured along the commissure posts. The tubular base of the support stent may be self-expandable or balloon-expandable. The fabric section of the tubular flexible member surrounds the tubular base of the support stent for contacting an annulus of the native heart valve.

A method of implanting a prosthetic heart valve includes advancing the prosthetic heart valve in a radially-contracted configuration into an annulus of a native aortic valve. The prosthetic heart valve includes a self-expanding body and a plurality of leaflets fastened to the body. The body of the prosthetic heart valve is formed with an annulus anchoring section, a sinus section, and an outflow section. During implantation, the prosthetic heart valve is allowed to self-expand such that the annulus anchoring section contacts the annulus of the native aortic valve and the outflow section contacts a native ascending aorta. The outflow section is less rigid than the annulus anchoring section for conforming to the native ascending aorta. The outflow section flares outwardly from the sinus section. The sinus section preferably includes three sinus apertures.

A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive.

A prosthetic valve is provided for implantation in a stenosed aortic valve. The prosthetic valve includes a radially collapsible frame configured for advancement through a patient's vasculature using a catheterization technique. A collapsible valvular structure is sewn to the frame for permitting blood to flow in only one direction. An internal cover extends along an internal surface of the frame. The internal cover forms a tubular sleeve positioned between a lower extremity of the frame and the valvular structure. The internal cover prevents the passage of blood through spaces between bars of the frame. An upper end of the internal cover is sutured to the valvular structure. The internal cover is preferably made of pericardium.

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.