Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

Abstract: In some embodiments, a prosthetic valve assembly includes an annular frame being radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, and a valvular structure comprising a plurality of leaflets mounted inside the annular frame. The annular frame includes a plurality of posts. Each post has a pair of commissure attachment members extending away from the post. Each pair of commissure tabs is attached to a corresponding pair of the commissure attachment members.

Abstract: Methods and systems for rotationally aligning cusps of a prosthetic heart valve with cusps of a native valve are disclosed. As one example, a method includes advancing a distal end portion of a delivery apparatus toward a native valve of a heart, a prosthetic heart valve radially compressed around the distal end portion, and visualizing under fluoroscopy, within an imaging view, a position one or more radiopaque markers disposed on the distal end portion relative to one or more native valve cusps. The method further includes rotating the distal end portion until the one or more markers are circumferentially aligned with a middle of the one or more native valve cusps and deploying the radially compressed prosthetic heart valve with the delivery apparatus to radially expand the prosthetic heart valve in the native valve such that the cusps of the prosthetic heart valve and the native valve are circumferentially aligned.

Abstract: A method for treating a heart valve involves delivering a catheter into a ventricle of a heart, advancing a coil from the catheter, rotating the coil at least partially around a papillary muscle of the ventricle, embedding a distal end of the coil in tissue of the ventricle, and manipulating a suture coupled to the coil to adjust a position of the papillary muscle.

Abstract: A method treating a deficient native mitral valve includes advancing the distal end portion of a delivery catheter into a heart, wherein the delivery catheter contains a support band stretched into a linear form, wherein the support band comprises a shape-memory material, and then ejecting the support band from the distal end portion of the delivery catheter such that the support band transitions from the linear form to a curved shape extending around native leaflets of the native mitral valve.

Abstract: A prosthetic valve can include a radially expandable and compressible frame having a plurality of struts, each strut having a first end, a second end, and a length extending from the first end to the second end. Each strut further including a plurality of recesses disposed on one or more longitudinal edges of the strut and extending into a width of the strut. The prosthetic valve further including a valvular structure disposed within and coupled to the frame, the valvular structure comprising a plurality of leaflets, and a skirt mounted to the frame via one or more sutures. The recesses retain the one or more sutures and prevent the one or more sutures from sliding along the length of the strut.

Abstract: A retrieval device for retrieving a previously implanted device from a native valve of a patient's heart includes one or more retrieval components. The retrieval components include one or more of a device securing member, a device actuation member, and a clasp capturing member. The securing member is configured to attach the retrieval device to the previously implanted device. The actuation member engages the previously implanted device to move the previously implanted device from a closed configuration to an open configuration. The clasp capturing member is configured to attach to a clasp of the previously implanted device.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The clasps include a fixed arm and a plurality of movable arms. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

Abstract: The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements may lie against or near the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.

Abstract: A delivery system for delivering a stent-mounted heart valve, or other implant, through an introducer sheath. The delivery system includes an elongate catheter supporting a capsule. The capsule contains the stent-mounted heart valve in the crimped condition. The capsule includes a protrusion extending from its outer surface for urging the sheath away from the outer surface capsule as it moves therethrough, thereby reducing an average peak push force resulting from advancement of the capsule through the sheath.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct including one or more leaflets. In some examples, the leaflet construct is coupled to the leaflet frame via a retention element. In some examples, the retention element is in the form of an outer frame that is coaxially arranged with the leaflet frame.

Abstract: Anchor devices and methods used to secure a prosthetic valve to a native valve annulus are described. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.

Abstract: A radially expandable prosthetic valve can comprise an annular frame, at least one expansion mechanism and a cord. The annular frame can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The expansion mechanism can comprise a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. The cord can extend at least partially along the expansion mechanism in a first direction, be reeved around a portion of the second member, and extend at least partially along the expansion mechanism in a second direction opposite the first direction. Applying a proximally directed force to a first portion of the cord can cause the second member to move relative to the first member, which can cause the frame to foreshorten axially and expand radially.

Abstract: A delivery apparatus can include a handle, a first shaft extending from the handle and having a proximal end portion coupled to the handle and a distal end portion and a second shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion. The delivery apparatus can further include a shoulder coupled to the distal end portion of the second shaft and having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, an extension portion extending from the shoulder, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

Abstract: Disclosed herein is a combined introducer and expandable sheath having an inner member and an outer elastomeric jacket. The inner member has radially folded tapered segments in an unexpanded state that are mechanically unfolded and moved toward the inner wall of the elastomeric jacket by a medical device moving through the lumen of the inner member. The compressive outer elastomeric jacket returns the expanded inner member back to the radially folded, unexpanded state once the medical device has passed through the expanded lumen of the inner member. The structure can include a distal region that tapers to a rounded tip. The proximal region also tapers to mate with a hemostasis value housing.

Abstract: A method of implanting a balloon expandable prosthetic valve within a native aortic valve includes introducing a delivery system into a femoral artery of a patient, the delivery system comprising an outer sleeve and a shaft extending through a lumen of the outer sleeve. A distal end portion of the shaft is positioned distal to a distal end of a steerable distal end portion of the outer sleeve. A prosthetic valve is crimped over a balloon disposed along the distal end portion of the shaft. The delivery system further comprises a first radiopaque marker inside the balloon and positioned adjacent a proximal end of the prosthetic valve and a second radiopaque marker inside the balloon and positioned adjacent a distal end of the prosthetic valve. The method also includes identifying a location of the prosthetic valve by monitoring the first and second radiopaque markers inside the balloon under fluoroscopy.

Abstract: Prosthetic valves that include support arms extending from support posts thereof, and methods for utilizing such prosthetic valves, are disclosed herein. As one example, a prosthetic valve can include an annular frame movable between a radially compressed state and a radially expanded state, and at least one support arm. The frame can include a plurality of support posts, each extending between a post inflow end and an opposite post outflow end. The support arm can extend from a corresponding support post, and terminate at a free-ended tip which is biased radially away from the corresponding support post.

Abstract: Leaflet perforation tools and associated methods. A leaflet perforation tool can comprise a catheter, a lacerating member configured to pierce a leaflet to form a pilot puncture, and an expansion member configured to expand the pilot puncture into a leaflet opening. In another example, a leaflet perforation tool can comprise a catheter and a nosecone that comprises at least one blade. The nosecone can form a leaflet opening in a leaflet, and blade can form a leaflet slit that is connected to the leaflet opening. A method can comprise forming a leaflet opening within a leaflet with a leaflet perforation tool, positioning a replacement prosthetic valve within the leaflet opening, and radially expanding the replacement prosthetic valve. A method also can comprise forming a pilot puncture within a leaflet and expanding the pilot puncture into a leaflet opening.