Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: A delivery device includes a catheter, and an inflatable balloon coupled to the catheter, the inflatable balloon forming a leading pillow and a trailing pillow spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat therebetween to retain a prosthetic heart valve during tracking of the delivery device.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: A prosthetic heart may include an expandable frame and prosthetic leaflets that each have a free edge, an attached edge having a contour, a first flat surface facing toward the frame, and a second flat surface facing away from the frame. A spacer fabric may be attached to each leaflet, the spacer fabric having a first surface, a second surface, and an inner matrix between the first and second surfaces.

Abstract: When generating anatomical maps (e.g., anatomical geometries and/or electrophysiology maps), it can be desirable to analyze whether or not a collected data point was collected from a region of interest. During an electrophysiology study, for example, an electroanatomical mapping system collects electrophysiology data points, each including an electrogram signal. By defining both a window of interest and a window of exclusion within the electrogram signal, the electroanatomical mapping system can analyze collected data points to determine whether or not they should be included in a map. In particular, the electroanatomical mapping system can compare the electrophysiology signal within the window of interest and the window of exclusion with respect to at least one signal parameter and add the data point to the map if the comparison satisfies at least one corresponding inclusion criterion. Applicable signal parameters include maximum peak-to-peak voltage, conduction velocity, and electrogram morphology.

Abstract: A method of modifying contact status of one or more electrodes in a plurality of electrodes located on a medical device includes measuring an electrical characteristic of each electrode in the plurality of electrodes located on the medical device, determining a contact status for each electrode in the plurality of electrodes based on the measured electrical characteristic for the corresponding electrode, wherein the contact status is indicative of contact with adjacent tissue. The method further includes modifying the contact status of a first electrode in the plurality of electrodes based on the determined contact status of one or more other electrodes in the plurality of electrodes.

Abstract: In some embodiments, a prosthetic heart valve system, includes a stent having a plurality of commissure attachment features, a cuff coupled to the stent, a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and a plurality of patches, each of the plurality of patches being disposed about a selected one of the plurality of commissure attachment features and coupled thereto, the plurality of leaflets being coupled to plurality of patches.

Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator coupled to the inner shaft.

Abstract: A deflectable catheter shaft with compression resistance coils configured to create different curve shapes when the catheter is steered or deflected in different directions. One or more compression resistance coils may include an elongated-pitch section. The compression resistance coils may be pull wire compression coils or body compression coils.

Abstract: The present disclosure provides electroporation catheters that are capable of forming a loop, generally a circular loop, an oval loop, or like in shape, located on the distal end portion of a catheter shaft within the vasculature of an individual. The electroporation catheters of the present disclosure may be delivered into the vasculature of the individual in a straight conformation and allow for the formation of the loop once positioned in the desired location. Some embodiments of the present disclosure include an electroporation catheter that includes a loop member pull wire in a spiral or helical configuration on an inside surface of the distal end portion of the catheter shaft.

Abstract: A method of determining contact status of electrodes includes applying drive signals between pairs of electrodes, measuring a bipolar electrode complex impedance (BECI) value generated in response to the drive signals over a collection period, and determining a baseline BECI value representing a minimum value measured during the collection period. The method further includes determining contact status of the electrode by applying drive signals between pairs of electrodes over a given interval, measuring a BECI value generated in response to the drive signals, measuring a peak-to-peak value associated with the BECI values measured over the given interval, and determining contact status based on a combination of the baseline BECI value, the measured BECI value, and the peak-to-peak value associated with the measured BECI values.

Abstract: An animated electrophysiology map is generated from a plurality of data points, each including measured electrophysiology information, location information, and timing information. The electrophysiology and location information can be used to generate the electrophysiology map, such as a local activation time, peak-to-peak voltage, or fractionation map. Animated timing markers can be superimposed upon the electrophysiology map using the electrophysiology, location, and timing information. For example a series of frames can be displayed sequentially, each including a static image of the electrophysiology map at a point in time and timing markers corresponding to the state or position of an activation wavefront at the point in time superimposed thereon. The visibility or opacity of the timing markers can be adjusted from frame to frame, dependent upon a distance between the timing marker and the activation wavefront, to give the illusion that the timing markers are moving along the electrophysiology map.

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: Embodiments of the present invention provide an improved vascular occlusion device for occlusion of a passageway, cavity, or the like. According to one embodiment, a medical device for occluding a left atrial appendage is provided. The medical device includes a first portion having at least one plane of occlusion that is configured to be positioned outside of the left atrial appendage, and a second portion having at least one plane of occlusion that is configured to be at least partially positioned within a cavity defined by the left atrial appendage.

Abstract: An impedance location of an electrode in an impedance based coordinate system and a magnetic location of a magnetic position sensor in a magnetic based coordinate system can be received. A transformed impedance location of the magnetic position sensor can be computed. A difference between the transformed impedance location of the magnetic position sensor and the magnetic location of the magnetic position sensor can be determined. A magnitude of the difference between the impedance location of the magnetic position sensor and the magnetic location of the magnetic position sensor can be computed. A statistical significance of the difference between the transformed impedance location of the magnetic position sensor and the magnetic location of the magnetic position sensor can be computed. A determination can be made that an impedance shift exists if the magnitude of the difference exceeds a threshold and a statistical significance of the difference exceeds a threshold.

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 is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.

Abstract: A catheter (e.g., high-density mapping catheter) and related catheter system is described herein. The catheter includes an elongated catheter shaft, and an electrode assembly. The electrode assembly includes a first spline assembly, a second spline assembly, and a distal coupler assembly. Each of the spline assembly includes a distal portion and spline assembly electrodes distributed along the spline assembly. The distal coupler assembly includes a base member and a distal electrode. The base member defines an opening configured to receive and accommodate the distal portion of the second spline assembly. The distal electrode is configured to be mounted to the base member to secure the distal portion of the second spline assembly within the opening. The distal electrode can be configured for cardiac mapping, tissue ablation, and/or bipolar pacing.

Abstract: A three-dimensional geometric model of a heart can be generated from a plurality of two-dimensional image slices of the heart collected using an intracardiac echocardiography (“ICE”) catheter. Each image slice can be associated with localization information for the ICE catheter. The image slices can be output in a plurality of voxels according to their associated localization information, thereby creating a three-dimensional geometric model of the heart. Data sufficiency of the three-dimensional model can also be graphically represented. For example, data sufficiency can be represented using voxel opacity, a one-dimensional illustration, a two-dimensional illustration, and/or a data collection cue.

Abstract: Systems, apparatuses and methods are provided for identifying the position of a catheter relative to internal tissue and controlling injection of a therapeutic substance(s) into the internal tissue. In one embodiment, a catheter includes one or more position sensing electrodes disposed at or near a distal end of the catheter that allow identifying the position of the catheter relative to the internal tissue. The catheter also includes one or more contact sensors that provide an indication of contact and/or contact forces between the catheter and internal tissue before and after a therapy delivery needle is extended from the catheter into the internal tissue. Outputs of the contact sensor(s) allows for confirming insertion of the therapy delivery needle into the internal tissue to a desired depth. Once inserted to the desired depth, a therapeutic substance may be injected into the internal tissue at the desired depth.

Abstract: A prosthetic heart valve may include a collapsible and expandable frame that, in an expanded condition, includes a central portion, an atrial portion flaring radially outwardly from the central portion, and a ventricular portion flaring radially outwardly from the central portion. A tube positioned within the frame may have a lumen extending along a longitudinal axis of the frame, wherein the tube is formed of tissue or fabric. Prosthetic leaflets may be directly coupled to the tube to form a valve allowing blood to flow through the lumen of the tube in an antegrade direction but substantially blocking blood from flowing through the lumen of the tube in a retrograde direction. A plurality of cords may each have a first end coupled to the frame and a second end coupled to the tube. Each of the plurality of cords may extend in a radial direction toward the longitudinal axis.