Abstract: A prosthetic heart valve includes an inner frame having a longitudinal axis, a plurality of prosthetic leaflets coupled to the inner frame, the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis and to substantially block blood from flowing through the inner frame in a retrograde direction along the longitudinal axis, an outer frame connected to the inner frame, and a sealing feature coupled to the inner frame at a coupling point and extending partially, but not completely, between the coupling point and a point of the outer frame that is radially outward of the coupling point in a direction substantially orthogonal to the longitudinal axis, and wherein in an implanted condition, the sealing feature is positioned such that backpressure from ventricular systole acts on the sealing feature.

Abstract: A prosthetic heart valve for replacing a native atrioventricular valve may include a self-expanding stent formed as a monolithic structure. The stent may include an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk. A plurality of prosthetic leaflets may be directly coupled to the center portion of the stent. An outer fabric may be coupled to the stent. In an implanted condition of the prosthetic heart valve, the atrial disk is sized to contact an atrial side of the native atrioventricular valve, the ventricular disk is sized to contact a ventricular side of the native atrioventricular valve, the center portion is sized to be positioned radially inside the native atrioventricular valve without pressing against the native atrioventricular valve, and the outer fabric is configured to directly contact the native atrioventricular valve.

Abstract: A medical device delivery system includes a steering catheter including a first steering ring having a plurality of apertures positioned in the wall of the first steering ring. The plurality of apertures are positioned at spaced distances around a circumference of the first steering ring. A first steering cable passes through a first one of the apertures, and a first return cable passes through a second one of the apertures. A second steering cable passes through a third one of the apertures, and a second return cable passes through a fourth one of the apertures. The first steering cable is positioned about 180 degrees from the second steering cable. A handle is operably coupled to a proximal end of the steering catheter. A first control member controls the first steering and first return cable, and a second control member controls the second steering and second return cable.

Abstract: A system comprising a prosthetic heart valve having a frame, prosthetic leaflets within the frame configured to allow blood to flow through the prosthetic heart valve in an antegrade direction but to substantially block blood from flowing through the prosthetic heart valve in a retrograde direction, an anchor configured to be secured against a ventricular apex of a heart of a patient, a tether coupled to the frame and through the anchor, and an end of the tether configured to extend beyond the anchor when the tether is fixed to the anchor, and a tether adjustment member having a collapsible tube defining an open leading end configured to receive the second end of the tether, and a wire leader extending from a second trailing end of the tube.

Abstract: Apparatus and methods are described herein for use in in establishing an improved AV loop with the use of a pulley/snare device at the base of a ventricle of a heart. In some methods described herein, a pulley/snare device is established to create a path with inherent concentricity to the aortic and mitral valves, allowing the valves to function normally during an interventional procedure in the heart, without impeding the motion of any leaflets. The pulley/snare device described herein minimizes the forces that are applied on the valves or associated cardiac tissue to “make the turn” from the aortic valve to the mitral valve.

Abstract: A prosthetic mitral valve includes a stent frame and an anchor assembly coupled to and peripherally surrounding the stent frame. The anchor assembly includes atrial anchors on the inflow end, ventricular anchors on the outflow end, and a central waist portion disposed therebetween. The anchor assembly generally defines an hourglass shape wherein the atrial and ventricular anchors flare radially outward and the central waist portion has a relatively smaller diameter. The prosthetic valve may include a gasket disposed peripherally around the central waist portion to seal the space between the body of the valve and the native valve annulus to prevent paravalvular leakage without increasing the profile of the valve to allow for smooth insertion into and deployment from a delivery device. The prosthetic valve may alternatively include a sealing fabric surrounding the anchor assembly defining a radial protrusion around the central waist portion to seal the native annulus.

Abstract: A prosthetic heart valve includes a collapsible and expandable outer frame, a collapsible and expandable inner frame, and a prosthetic valve assembly. The outer frame may be configured to engage tissue of a native heart valve, and may have (i) an atrial portion adapted to be positioned on an atrial side of the native heart valve; (ii) a ventricle portion adapted to be positioned on a ventricle side of the native heart valve; and (iii) a narrowed waist portion between the atrial portion and the ventricle portion. The inner frame may be positioned radially inward of the outer frame and may be coupled to the outer frame. A constraining band may extend around a circumference of the inner frame. The prosthetic valve assembly may be coupled to, and positioned radially inward of, the inner frame.

Abstract: Apparatus and methods are described herein for use in in establishing an improved AV loop with the use of a pulley/snare device at the base of a ventricle of a heart. In some methods described herein, a pulley/snare device is established to create a path with inherent concentricity to the aortic and mitral valves, allowing the valves to function normally during an interventional procedure in the heart, without impeding the motion of any leaflets. The pulley/snare device described herein minimizes the forces that are applied on the valves or associated cardiac tissue to “make the turn” from the aortic valve to the mitral valve.

Abstract: Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when the valve is in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The distal end portion of the delivery sheath is inserted into a left atrium of a heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. In some embodiments, actuation wires are used to assist in the reversion of the outer frame. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.