Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a pair of paddles, a coaption element, and a covering. The coaption element has a first end portion and a second end portion. The coaption element is connected to the pair of paddles. The covering is disposed over the caption element. The covering prevents blood from flowing through the caption element.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element; a pair of paddles connected to the coaption element; a catch point formed by a portion of at least one of the coaption element and the pair of paddles when the paddles are in the open position; and a cover covering connected to the coaption element and the paddles for covering the catch point. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a strip of material having first and second edges surrounding a central portion; a coaption element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a collar; a coaption element attached to the collar; and a pair of paddles are connected to the coaption element. The collar has a plurality of engagement portions configured to releasably engage a delivery apparatus. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The paddles are circumferentially disposed between the engagement portions.

Abstract: An implantable prosthetic valve can include a radially expandable and collapsible annular frame comprising an inflow end and an outflow end and a plurality of struts forming a plurality of cells, where each of the plurality of cells defines an opening in the frame. A leaflet structure can be positioned within the frame and secured thereto. A plurality of sealing members can be secured to the plurality of struts of the frame, where each sealing member of the plurality of sealing members includes two opposite sides that are not secured to the frame to allow blood to flow through each sealing member along a path formed between the frame and the sealing members.

Abstract: In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly, a pair of paddles, and a pair of gripping members. The base assembly includes a shaft and a coupler attached to the shaft such that the coupler can be moved along the shaft. The paddles are movable between an open position, a closed position and a bailout position. The paddles and the gripping members are configured to attach to the native valve of the patient. Movement of the coupler along the shaft causes the paddles to move between the open position, the closed position, and the bailout position. When the paddles are in the bailout position, a bailout angle between each paddle of the pair of paddles and the shaft is greater than or equal to 120 degrees.

Abstract: In one embodiment, a delivery assembly can comprise an annular frame, a leaflet structure positioned within the frame and secured thereto, and an outer skirt positioned around an outer surface of the frame. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The outer skirt can comprise pericardial tissue having a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt. The outer skirt can be positioned such that the first surface is facing away from the frame and the second surface is facing towards the frame.

Abstract: Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially-inwardly of the inner surface of the first leaflet.

Abstract: Embodiments of a leaflet clip device and method of reducing regurgitation through a native heart valve are disclosed. A leaflet clip device can include an elongated clipping member having a first end portion and a second end portion and a tensioning mechanism coupled to the clipping member. The leaflet clip device can further include one or more tensioning members disposed within a lumen of the clipping member, wherein the one or more tensioning members are operatively connected to the tensioning mechanism to transform the clipping member from a delivery configuration to an implantation configuration.

Abstract: A prosthetic heart valve can include a frame, a valve component, and a sealing member. The frame can have an inflow end portion, an outflow end portion, an intermediate portion disposed between the inflow and outflow end portions, and a plurality of struts. The frame can be radially compressible and expandable between a radially-compressed configuration and a radially-expanded configuration. The valve component can be disposed within and coupled to the frame and have a plurality of leaflets. The sealing member can have a plurality of ribs and a plurality of drapes. The ribs can be coupled to and extend radially outwardly from the frame when the frame is in the radially-expanded configuration. The drapes can be coupled to and extend radially between the frame and the ribs. The sealing member can be configured to reduce or prevent perivalvular leakage around the prosthetic heart valve.

Abstract: A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

Abstract: A method for manufacturing a heart valve using bioprosthetic tissue that exhibits reduced in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

Abstract: A method of implanting a prosthetic mitral valve includes advancing a delivery apparatus into a left side of a patient's heart and deploying a support structure from the delivery apparatus. The support structure extends around native mitral valve leaflets such that the native leaflets are disposed radially within the support structure. The method also includes advancing a prosthetic heart valve within the native leaflets. The prosthetic heart valve is separate from the support structure and includes an annular frame and a valve structure positioned within the annular frame, and prosthetic heart valve is in a radially collapsed configuration. The method further includes expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration. In the radially expanded configuration, the annular frame of the prosthetic heart valve engages the native leaflets and is separated from the support structure by the native leaflets.

Abstract: Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can them move distally to prepare to deploy the next suture clip.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: A contoured biological tissue for a bioprostheses, such as a cardiac/vascular patch or a bioprosthetic heart valve, and methods of contouring the tissue, are described. A predetermined pattern is provided on the tissue, comprising a plurality of ridges or depressions that are configured to facilitate cellular migration in a first direction and discourage cellular migration in a second direction. The biological tissue can be used in connection with a bioprosthetic heart valve comprising a biological tissue leaflet structure coupled to a supporting frame.

Abstract: An implantable prosthetic device can include a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member can be configured to be disposed between native leaflets of a heart. The anchors can be coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps can be coupled to a respective anchor and configured to secure the native leaflets to the anchors. The clasps can be independently movable between an open configuration and a closed configuration.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Abstract: A pair of paddles are moved laterally away from one another in an exemplary method of repairing a native valve of a patient during a non-open-heart procedure. After the paddles are moved laterally away from one another, first and second gripping members are moved from an open position to a closed position to grasp valve leaflets. The paddles are then moved laterally toward one another. A cam can be used to move the paddles away from one another.