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 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: 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 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 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: The present disclosure describes delivery cables for delivering a medical device. In one embodiment, a delivery cable includes a flexible inner core, a proximal outer coil, and a distal outer coil. The proximal outer coil has a first rigidity. The distal outer coil surrounds at least a portion of a distal section of the flexible inner core and has a second rigidity less than the first rigidity thereby, thereby reducing bias placed on the medical device by the delivery cable.

Abstract: An elongate medical device comprising an expandable structure with an expandable configuration and a collapsed configuration, a handle, operably coupled to the expandable structure, the handle further including a selective movement limiter; and a deflection control member coupled with the distal hub, where the deflection control member is configured to adjust a stiffness of the expandable structure, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness when the selective movement limiter couples with the deflection control member and limits a longitudinal movement of the deflection control member, and wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.

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.

Abstract: A prosthetic heart valve includes a stent body and prosthetic leaflets. The stent body extends from an inflow end to an outflow end and includes an annulus section defining a first row of cells extending in a circumferential direction, the stent body being expandable from a delivery condition having a first diameter to a deployed condition having a second diameter larger than the first diameter. The prosthetic leaflets are mounted to the stent body allow flow in an antegrade direction but substantially block flow in a retrograde direction. The first row of cells is circumferentially continuous in the delivery condition and in the deployed condition, and the stent body is further expandable from the deployed condition to an open condition in which the first row of cells is circumferentially discontinuous.

Abstract: A catheter comprises an expandable spline structure defining a distal tip portion of the catheter. The spline structure comprises a plurality of individual splines, and each spline is configured to support a plurality of energy transfer elements and/or temperature sensors. An expandable balloon configured to be associated with the spline structure is unattached to the spline structure along its length.

Abstract: Arrhythmic foci and other driver sites can be mapped using a multi-dimensional catheter. For instance, using a clique of three or more electrodes on the multi-dimensional catheter, an electroanatomical mapping system can identify a maximum bipolar voltage and an average unipolar voltage. The ratio of the average unipolar voltage to the maximum bipolar voltage can be interpreted as an indication of whether a cardiac location is an arrhythmic focus. Alternatively, an evaluation region can be defined about location in the patient's heart. The evaluation includes a plurality of rods, each associated with a respective E-field loop having a respective maximum and minimum amplitude bipole axes, with the rods being defined by the maximum amplitude bipole axes. For a sufficient number of rods within the evaluation region, a focus score for the evaluation region can be computed to reflect rod orientation consistency within the evaluation region.

Abstract: A prosthetic heart valve may include an expandable stent having a plurality of struts forming cells connected to one another in a plurality of annular rows around the stent, a cuff attached to an annulus section of the stent by cuff sutures that have a plurality of stitches extending through material of the cuff and looping around the struts, and a plurality of leaflets each having a belly attached to the cuff within an interior region of the stent. The leaflets may together have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. The belly of each leaflet may be attached to the cuff by leaflet sutures extending in a path that crosses some of the struts in overlap zones. Those struts may be devoid of the stitches within the overlap zones.

Abstract: A prosthetic heart valve includes a radially collapsible and expandable stent, a cuff and leaflets sutured thereto. The heart valve extends axially between an inflow end and an outflow end and the stent includes a layout of struts and nodes having a hybrid combination of vertical struts and oblique struts in the form of diamond-shaped and half diamond-shaped cells. The layout of the structure is configured to preserve a low cell density of material used in the stent to reduce the stent profile while in a collapsed state and to improve the deployment accuracy of the stent into the native valve annulus.

Abstract: Various embodiments of the present disclosure provide a medical device straightener. The medical device straightener can comprise an elongate shaft extending along a shaft longitudinal axis, the elongate shaft including a shaft proximal end and a shaft distal end, wherein a shaft inner wall of the elongate shaft defines a shaft lumen extending therethrough. The medical device straightener can comprise a bleedback valve that includes an outer circumferential surface. The bleedback valve can be disposed at a distal end of the elongate shaft, within the shaft lumen, wherein a portion of the outer circumferential surface is in communication with the shaft inner wall. The bleedback valve can define a radially expandable lumen longitudinally extending through a center of the bleedback valve.

Abstract: The present disclosure provides electroporation systems and methods of energizing a catheter for delivering electroporation. A catheter for delivering electroporation includes a distal section and an electrode assembly. The distal section is configured to be positioned in a vein within a body. The vein defines a central axis. The electrode assembly is coupled to the distal section and includes a structure and a plurality of electrodes distributed thereabout. The structure is configured to at least partially contact the vein. Each of the electrodes is configured to be selectively energized to form a circumferential ring of energized electrodes that is concentric with the central axis of the vein.

Abstract: A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.

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: A steerable introducer deflectable via a handle assembly is described. The handle assembly includes slide members disposed within a slide chassis and coupled to deflection wires to deflect the introducer, and a slide block divider for constraining slide members. The slide block divider and the slide chassis combine to form a slide compartment in which each of the first slide member and the second slide member is slidably disposed. The slide block divider can prevent the deflection wires from crossing each other within the handle assembly, and constrain each of the slide members during translation within the slide compartment to inhibit motion transverse to a longitudinal direction of the slide compartment. The slide block divider can provide an improved handling of the steerable introducer.