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: A delivery apparatus for a medical device can include a handle, a shaft, a plurality of sleeves, and a suture. The shaft includes a proximal end portion coupled to the handle and is configured to be disposed outside of a patient's body during an implantation procedure and a distal end portion configured to be disposed inside a patient's body during the implantation procedure. Each of the sleeves includes a connection portion coupled to the distal end portion of the shaft and a receiving portion configured to receive an apex of a stent or a prosthetic heart valve. The suture extends through the shaft and the sleeves and is configured for releasably securing the stent or the prosthetic heart valve to the receiving portions of the sleeves.

Abstract: Outer skirts for a prosthetic heart valve are disclosed. As one example, a prosthetic heart valve can include an annular frame and an outer skirt disposed around an outer surface of the frame. The outer skirt can include a first portion comprising a polymeric material and a second portion comprising a fabric, where the polymeric material has a greater thromboresistance than the fabric.

Abstract: Examples of transection devices are disclosed. One example includes an elongated body having a U-shaped notch, wherein the U-shaped notch includes a wall surface extending from a surface of the elongated body and an upper extension extending from the wall surface substantially parallel with the longitudinal axis of the elongated body. An incision member located in the U-shaped notch preferably extends from the elongated body toward the extension of the U-shaped notch at an angle. The incision member is well suited for cutting pericardial tissue as it passes through the U-shaped notch.

Abstract: Disclosed is a medical device comprising an incision assembly coupled to a catheter and an incision opening defined along the incision assembly. A retractable cutting apparatus is disposed within the incision opening and comprises a first incision member comprising at least one first cutting surface and defining a first member proximal end rotatably fixed proximate to a distal end of the incision opening and the at least one cutting surface is located on a bottom edge of the first incision member. A second incision member comprises at least one second cutting surface and defines a second member distal end attached to the first incision member at a connection point between a first member distal end and the first member proximal end of the first incision member, and wherein the at least one second cutting surface is located on a bottom edge of the second incision member.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Abstract: A method of implanting a prosthetic heart valve includes selecting a prosthetic heart valve. The selected prosthetic heart valve has a nominal diameter that is greater than a native annulus diameter of a native annulus by up to forty percent. The method further comprises compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the nominal diameter, positioning the selected prosthetic heart valve within the native annulus, and expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration in which the selected prosthetic heart valve has a second diameter which is less than the nominal diameter by up to ten percent and which is greater than the first diameter.

Abstract: A prosthetic heart valve including a frame, leaflet structure, and sealing member disposed around an outer surface of the frame is disclosed. An inflow end of the frame is defined by a plurality of spaced apart inflow apices. As one example, the sealing member has a circumferentially extending inflow edge and a circumferentially extending outflow edge, where the inflow edge is attached to the plurality of inflow apices, and where the inflow edge has an undulating shape around a circumference of the frame.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a method can include advancing a distal end portion of an assembly toward a native heart valve, the assembly comprising a delivery apparatus and a prosthetic heart valve, and including one or more radiopaque markers, where one radiopaque marker is suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve. The method further includes receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus, determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation, and rotating the assembly until the prosthetic heart valve is in the desired rotational orientation.

Abstract: Methods and assemblies for attaching leaflets to a frame of a prosthetic heart valve using a connecting skirt are disclosed. As one example, a prosthetic heart valve can include an annular frame comprising a plurality of struts and a valvular structure mounted within the frame and comprising a plurality of leaflets. A cusp edge portion of each leaflet can be connected to the frame by a connecting skirt, where each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion, and each connecting skirt can further comprise side extension portions that extend away from the cusp edge portion of the leaflet and across a portion of cells of the frame that are disposed between cusp edge portions of adjacent leaflets, and covers at least one entire cell of the portion of cells.

Abstract: 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 a knitted fabric layer, the knitted fabric layer comprising a base layer forming an inner surface of the knitted fabric layer, where the base layer has a mesh-like structure. The knitted fabric layer further comprises a plush outer surface comprising a plurality of pile yarns knit into loops and that extend outward from the base layer.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Abstract: Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Abstract: Methods and assemblies for attaching leaflets to a frame of a prosthetic heart valve using a connecting skirt are disclosed. As one example, a prosthetic heart valve can include an annular frame comprising a plurality of struts and a valvular structure mounted within the frame and comprising a plurality of leaflets. A cusp edge portion of each leaflet can be connected to the frame by a connecting skirt, where each connecting skirt comprises a central portion and opposing side base portions on opposite sides of the central portion that are connected to each of and disposed between the frame and the cusp edge portion of the leaflet and each connecting skirt can further comprise side extension portions that extend outward from the cusp edge portion of the leaflet and across struts of the frame that are disposed between cusp edge portions of two adjacent leaflets.

Abstract: Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Abstract: A system includes at least one electrode configured for transcutaneous stimulation of a pudendal nerve or surrounding perianal tissue or both. The at least one electrode is coupled to a substrate that includes a rectal portion and a buttocks support portion. The rectal portion includes a fecal blocking element. A control module is coupled to the at least one electrode, and includes a microprocessor for controlling operational parameters of the system.

Abstract: Methods and systems for attaching a radiopaque marker to a prosthetic heart valve to indicate a location of a commissure of the prosthetic heart valve are disclosed. As one example, a prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame arranged between an inflow end and an outflow end of the frame, a plurality of leaflets arranged within the frame, and at least one commissure comprising an attachment member arranged across a selected cell of the plurality of cells of the frame and commissure tabs of two adjacent leaflets coupled to the attachment member. The valve further includes a radiopaque marker arranged on the attachment member of the commissure within the selected cell.

Abstract: A delivery apparatus for a medical device can include a handle, a shaft, a plurality of sleeves, and a suture. The shaft includes a proximal end portion coupled to the handle and is configured to be disposed outside of a patient's body during an implantation procedure and a distal end portion configured to be disposed inside a patient's body during the implantation procedure. Each of the sleeves includes a connection portion coupled to the distal end portion of the shaft and a receiving portion configured to receive an apex of a stent or a prosthetic heart valve. The suture extends through the shaft and the sleeves and is configured for releasably securing the stent or the prosthetic heart valve to the receiving portions of the sleeves.

Abstract: A medical balloon sensing assembly constituted of: a handle; a first catheter extending distally from the handle; an inflatable medical balloon, the inflatable medical balloon secured by the first catheter; at least one sensor position member; and at least one sensor secured to the at least one sensor position member, wherein the at least one sensor position member is arranged to contact an outer face of the inflatable medical balloon.