A delivery system for delivery of an implantable stented device to a body lumen that includes an elongated member having a distal tip and a proximal end portion, a wire connection member positioned between the distal tip and proximal end portion of the elongated member, and a plurality of capturing wires extending from a distal end of the wire connection member. Each of the capturing wires includes a distal end having a lower portion that is moveable relative to an upper portion between an open position and a closed position, and a slot defined by the upper and lower portions when they are in the closed position.

A mechanical circulatory assist device is provided including a stent, a coiled wire wound around the stent, and a reciprocating valve including a housing, one or more leaflets coupled to the housing, and one or more permanent magnets coupled to the housing. The magnets are arranged to interact with a magnetic field generated by the coiled wire when current flows therethrough, so as to axially move the reciprocating valve with respect to the stent when the reciprocating valve is disposed within the stent. Upstream axial motion of the reciprocating valve causes the leaflets to be in an open state in which they allow blood flow through the reciprocating valve. Downstream axial motion of the reciprocating valve causes the leaflets to be in a closed state in which they inhibit blood flow through the reciprocating valve. Other embodiments are also described.

A transcatheter valve prosthesis includes a stent and a prosthetic valve. The stent is mechanically or balloon expandable. The stent has an inflow portion and an outflow portion. The inflow portion includes a plurality of side openings defined by a plurality of crowns and a plurality of struts. The outflow portion has three circumferentially spaced apart commissure posts. The prosthetic valve is disposed within and secured to at least the outflow portion of the stent. The prosthetic valve is configured to block blood flow in one direction to regulate blood flow through a central lumen of the stent. The commissure posts are configured to flex or bend flex radially inwardly to reduce stresses observed during valve loading and thereby improve or increase tissue durability of the prosthetic valve.

A delivery apparatus for an expandable, implantable medical device comprises a handle portion, a shaft extending from the handle portion, a delivery capsule configured to house the medical device in a radially compressed state, and a rotatable component disposed in the handle portion and operatively coupled to the delivery capsule to produce axial movement of the delivery capsule upon rotation of the rotatable component. The delivery apparatus further comprises a motor disposed in the handle portion that is operatively coupled to the rotatable component so as to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule. Further, the delivery apparatus comprises a manual deployment tool that is also configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.

A delivery apparatus for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts. The handle comprises one or more knobs, one or more adjustment mechanisms, and/or one or more control mechanisms. The knobs are configured for actuating the one or more adjustment mechanisms and/or the one or more control mechanisms. The one or more adjustment mechanisms are configured for moving the shafts relative to each other and/or relative to the handle. The one or more control mechanisms are configured for limiting the direction of movement and/or force applied to the one or more shafts.

A prosthetic heart valve including a frame, leaflet structure, and sealing member disposed around an outer surface of the frame is disclosed. As one example, the sealing member includes an inner layer and a plush outer layer comprising a plush outer surface. The inner layer is arranged against the outer surface of the frame and the outer layer is arranged against and attached to the inner layer. The inner layer is folded over at inflow and outflow ends, in an axial direction relative to a central longitudinal axis of the frame, to overlap respective ends of the outer layer and form tapered folds at opposite ends of the sealing member, each tapered fold including a narrower, first portion where the inner layer folds over and contacts itself and a wider, second portion where the inner layer overlaps an outer surface of an end portion of the outer layer.

A prosthetic mitral valve with improved blood flow to the left ventricular outflow tract (LVOT). The prosthetic mitral valve includes an expandable outer stent having an atrial end and a ventricular end, and an expandable inner stent attached to and at least partially positioned within the outer stent. The inner stent has an inflow end, an outflow end and a connector securing a tether. A valve assembly including a cuff and a plurality of leaflets may be disposed within the inner stent. The outer stent is expandable from a delivery condition in which the outer stent is axially elongated to a deployed condition in which a first portion of the outer stent is folded upon a second portion of the outer stent to define a flange for engaging an atrial surface of a native valve annulus and to stabilize the prosthetic heart valve within the native valve annulus.

A prosthetic heart valve comprises an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state. A plurality of leaflets are situated within the frame, each leaflet comprising a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body. Each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame. Each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

An assembly can include a prosthetic valve and a delivery apparatus having a handle and a plurality of actuator assemblies extending from the handle. The prosthetic valve can have a plurality of posts one or more of which are configured as actuators having an axially spaced first member and second member, and a threaded rod extending through first and second members. Each actuator assembly can include a first actuation member engaging an outflow end of the prosthetic valve and having first and second support extensions, and a second actuation member extending through the first actuation member and comprising a distal end portion having an engagement portion releasably coupled to the threaded rod. The first and second support extensions can inhibit rotation of the frame relative to the one or more actuator assemblies during expansion of the prosthetic valve.

A device for treating a diseased native valve in a patient includes a frame structure and a valve segment coupled to the frame structure. The frame structure has an unexpanded configuration and an expanded configuration. The valve segment has a plurality of leaflets, a seal, and a seal support. An inflow edge of the plurality of leaflets is unsupported by the frame structure. The seal is attached to the inflow edge of the plurality of leaflets and positioned radially between the frame structure and the plurality of leaflets. The seal support is attached to or within the seal and provides axial rigidity to the seal.