Abstract: According to one aspect of the disclosure, a prosthetic heart valve includes a collapsible and expandable frame that includes a central portion, and atrial and ventricular portions flaring outwardly from the central portion. A prosthetic valve is housed within the frame. An outer skirt is disposed on an outer surface of the frame, the outer skirt having a first end portion having a first attachment to the atrial portion or the ventricular portion, a second intermediate portion having a second attachment to the frame adjacent the central portion, and a third intermediate portion having a third attachment to the frame adjacent the central portion. Upon transition of the frame from the expanded condition to the collapsed condition, the first attachment does not translate relative to the frame, while the second and third attachments do translate relative to the frame.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis with a distal end and a proximal end. First and second pull wires can extend along the elongated body and can have a proximal end and a distal end. First and second pull wire liners can be disposed over a portion of one of the first and second pull wires, respectively. Each of the first and second pull wires can have a proximal end and a distal end. A first gap can exist between the proximal end of the first pull wire liner and the proximal end of the elongated body and a second gap can exist between the proximal end of the second pull wire liner and the proximal end of the elongated body.

Abstract: A prosthetic heart valve system may include a collapsible anchor frame which may include a support frame that has a central portion, and atrial and ventricular portions flared radially outwardly from the central portion. The atrial and ventricular portions may be sized to sandwich or clamp an annulus of the heart valve. An atrial sheet may be coupled to the atrial portion of the support frame and may extend radially inwardly to a central aperture in the atrial sheet, the atrial sheet being formed of a material that is substantially impermeable to blood. The system may include a leaflet support structure, an inflow end of the leaflet support structure coupled to the atrial sheet. The atrial sheet may define an opening positioned radially outside of the leaflet support structure so that blood flowing around an exterior of the leaflet support structure passes through the opening.

Abstract: Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial fibrillation.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter or more proximally located. Tip electrodes can be constructed from an electrically-insulative substrate covered with a conductive material. The conductive material can be deposited on the electrically-insulative substrate to form a single tip electrode or multiple segmented electrodes. In some embodiments the tip electrode can include irrigation flow holes for irrigation. A method of manufacturing a tip electrode comprising a thin layer of conductive material deposited on an electrically-insulative substrate is disclosed. Segmented ring electrodes can be constructed from segmented ring electrodes that can be equally separated around a circumference of a catheter. The segmented ring electrodes can be formed into segmented electrode subassemblies that can then be joined to a catheter shaft.

Abstract: Described herein is a medical device for treating a target site. The medical device includes a proximal end including a disc and a distal end including a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface, a distal surface, and a central surface extending between and connecting the proximal surface and distal surface, wherein the central surface separates the proximal surface from the distal surface by a predetermined depth distance.

Abstract: In some embodiments, a prosthetic heart valve system, includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and the stent having one or more retention tabs, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

Abstract: According to one aspect of the disclosure, a prosthetic heart valve system includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition and protect portions of the valve assembly during crimping and delivery.

Abstract: A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet includes a sewing edge and a free edge. The leaflet is formed from a sheet of leaflet material which is processed so that the resulting leaflet has a non-uniform thickness. Various methods may be used to form the leaflet with a non-uniform thickness.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent and including a cuff and a plurality of leaflets, each leaflet being attached to adjacent commissure features and to the stent struts and/or the cuff.

Abstract: A system and method for obtaining an OIS coordinate frame comprising an electronic control unit configured to determine a local 3D electric field loop, create a zero mean version of E(t) over a depolarization interval, compute an ? value at each of a plurality of time intervals, compute an initial estimate of ? from a cross product of E and the ? value for each of the plurality of time intervals, average the initial estimate of ? from each of the plurality of time for a best estimate of ?, determine a plurality of â(?) values and using the corresponding {circumflex over (n)}(?) values, compute a composite match score, and choose at least one best value for â and a best value for {circumflex over (n)}.

Abstract: An electrode support structure assembly in a body in accordance with one embodiment of the present teachings includes a plug defining a longitudinal axis. The plug includes a lumen extending in an axial direction and including an axial distal end and a distal tip adjacent to the axial distal end of the lumen and including a first channel. The assembly further includes a cap disposed around at least a portion of the plug and including a plurality of apertures and an interior. The assembly further includes a plurality of support members, each support member comprising a distal portion. The cap is configured to constrain relative movement of the distal portions of the plurality of support members with respect to the cap, and the first channel of the plug and at least one of the plurality of support members are configured to direct a fluid after exiting the lumen of the plug.

Abstract: A method of implanting a prosthetic heart valve includes delivering the prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped over a deflated balloon of a delivery device. The method may include advancing fluid through the delivery device and into the balloon to inflate the balloon and to expand the prosthetic heart valve into the native valve annulus. The method may include monitoring a pressure within the delivery device while advancing fluid through the delivery device. The method may also include displaying the monitored pressure on a display device in real time during monitoring the pressure.

Abstract: A prosthetic heart valve system includes a balloon expandable prosthetic heart valve and a delivery catheter. The prosthetic heart valve has an inflow end portion, an outflow end portion, and a center portion. The delivery catheter has a balloon assembly on a distal end portion of the delivery catheter having a proximal portion, a distal portion, and a center portion. In a delivery condition of the system, the prosthetic heart valve is crimped over the balloon while the balloon assembly is deflated.

Abstract: A prosthetic heart valve system may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal end portion of the delivery catheter. In a delivery condition of the system and in an activated condition of the system, the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and so that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve. In the activated condition of the system, the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve.

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 prosthetic heart valve for replacing a native valve includes a stent having a plurality of struts, an inflow end, an outflow end, a collapsed condition and an expanded condition. A valve assembly is disposed within the stent. A first cuff is annularly disposed adjacent the stent, and a second cuff is annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The second cuff is at least partly radiopaque and may assist in determining the relative position between the second cuff and a patient's anatomy using fluoroscopy during an implantation procedure.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The prosthetic valve includes a plurality of legs and a sealing portion that are biased to curl upon deployment of the valve to form a sealing ring at a spaced distance from the proximal end of the valve.