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.

Abstract: The instant disclosure relates to electrophysiology catheter for tissue ablation. In particular, the instant disclosure relates to a system controller for facilitating an ablation therapy at a cryogenic ablation balloon. In an embodiment, an ablation an ablation catheter system comprising a catheter shaft including proximal and distal ends, a catheter handle coupled to a proximal end of the catheter shaft, a cryogenic ablation ballon coupled to the distal end of the catheter shaft, the ablation ballon configured and arranged to deliver a cryogenic ablation therapy to target tissue, an ablation system controller coupled to the catheter handle.

Abstract: The present disclosure generally relates to medical devices and methods for navigating a catheter shaft into the body of a subject during an intracoronary or other medical procedure and controlling the distal end of the catheter shaft. The present disclosure includes the use of an introducer positioning device that may be used in combination with an introducer. The introducer positioning device when used in combination with an introducer allows a catheter shaft to be inserted therethrough and into the introducer shaft located in the introducer where a distal end of the catheter shaft is aligned with the distal end of the introducer shaft.

Abstract: Elongate medical devices with a deflectable shaft section include a lumen liner configured to enhance planarity control of the deflectable shaft section. An elongate medical device includes a deflectable shaft section, a lumen within the deflectable shaft section, and a lumen liner that surrounds and defines the lumen. The lumen liner has an in-plane bending stiffness and an out-of-plane bending stiffness that is greater than the in-plane bending stiffness to provide planarity control of the deflectable shaft section during the cross-sectional bending of the deflectable shaft section.

Abstract: Electrical activation of tissue can be mapped from using electrophysiological data from a plurality of electrodes carried by a high density grid catheter. Each clique of three or more electrodes will define a pair of orthogonal bipoles as well as several unipoles. An electroanatomical mapping system can analyze the electrophysiological data such that, for each clique, an integral of an omnipolar electrogram the best morphologically matches a representative (e.g., average) unipolar electrogram for the clique is identified. The orientation of the best-fit omnipole is then defined as the activation direction for the clique. The conduction velocity magnitude can also be computed as a ratio of an amplitude of the unipolar electrogram for the clique to an amplitude of the integral of the omnipolar electrogram for the clique along the activation direction. The resulting activation map can also be output graphically.

Abstract: A prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

Abstract: A prosthetic heart valve includes a stent extending in a longitudinal direction and having a collapsed condition and an expanded condition. The stent includes a plurality of struts forming cells and a plurality of commissure attachment features spaced apart in an annular direction of the stent and extending in a medial direction of the stent. A valve assembly is secured to the commissure attachment features, the valve assembly including a cuff and a plurality of leaflets, each of the leaflets having a free edge and being capable of alternating between an open position and a closed position. A method of manufacturing the prosthetic heart valve is also provided.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal to the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: The instant disclosure relates to electrophysiology catheters for tissue ablation within a cardiac muscle, for example. In particular, the instant disclosure relates to an electrophysiology ablation balloon catheter with a combination of coated and uncoated surfaces for focusing ablation energy at a desired portion of tissue.

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: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

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: The present disclosure provides electroporation systems, methods of controlling electroporation systems to limit electroporation arcs through intracardiac catheters, and catheters for electroporation systems. One method of controlling an electroporation system including a direct current (DC) energy source, a return electrode connected to the DC energy source, and a catheter connected to the DC energy source is disclosed. The catheter has a at least one catheter electrode. The method includes positioning the return electrode near a target location within a body and positioning the catheter electrode adjacent the target location within the body. A system impedance is determined with the return electrode positioned near the target location and the catheter electrode positioned within the body. The system impedance is adjusted to a target impedance to arcing from the catheter electrode.

Abstract: A medical device for treating a native heart valve may include a frame formed of shape-memory material, the frame including a central bar extending between a first leg and a second leg of the frame. The frame may be transitionable between a delivery condition and a deployed condition. The first leg and the second leg may each having a curved portion with a concave outer surface in the deployed condition. The concave outer surface may be sized and shaped to engage a corresponding native commissure of the native heart valve so that, when the frame is deployed within the native heart valve, the central bar bridges across the native heart valve.

Abstract: A location of a number of fiducial points can be computed. The fiducial points can include impedance locations of an electrode disposed on a catheter in an impedance based coordinate system and magnetic locations of a magnetic position sensor disposed on the catheter in a magnetic based coordinate system. The impedance location of the electrode in the impedance based coordinate system can be transformed into a transformed impedance location of the electrode in the magnetic based coordinate system. A magnetic location of the electrode in the magnetic based coordinate system can be determined. A determination of whether an impedance shift exists between the transformed impedance location of the electrode in the magnetic based system and the magnetic location of the electrode in the magnetic based system can be made. An electromagnetic dynamic registration can be generated between the impedance based coordinate system and the magnetic based coordinate system based on the impedance shift.

Abstract: An apparatus for cooling tissue or a fluid for an elongate medical device comprising an elongate shaft extending along a longitudinal axis and comprising a shaft proximal end and a shaft distal end; a support structure located at the shaft distal end, where the support structure is expandable from a contracted state to an expanded state, and a plurality of thermoelectric elements, wherein the thermoelectric elements are located on the support structure. A medical device comprising a first catheter end shape, a second catheter end shape located distally with respect to the first catheter end shape, a support structure that extends between the first and the second catheter end shape, and a plurality of thermoelectric elements. A system for cooling a tissue or a fluid for an elongate medical device, comprising a plurality of thermoelectric elements, a thermocouple, an electronic control unit (ECU).