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: 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 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: 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: 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: 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: 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 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 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 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.

Abstract: A method of determining a baseline impedance value for a first electrode in a plurality of electrodes located on a medical device for tissue contact detection includes measuring an impedance value of the first electrode generated in response to a drive signal to the first electrode. The method further includes assigning a baseline impedance value to the first electrode based on impedance values measured in a predetermined time interval and determining a confidence value associated with the baseline impedance value. The method further includes utilizing the baseline impedance value in determining contact status of the first electrode when the confidence value is at or above a predetermined threshold value.

Abstract: Cardiac activity can be mapped by receiving an electrogram, transforming the electrogram into the wavelet domain (e.g., using a continuous wavelet transformation) to create a scalogram of the electrogram, computing at least one energy function of the scalogram, and computing at least one metric of the electrogram using the at least one energy function. The metrics of the electrogram can include, without limitation: a QRS activity duration for the electrogram; a near-field component duration for the electrogram; a far-field component duration for the electrogram; a number of multiple components for the electrogram; a slope of a sharpest component of the electrogram; a scalogram width; an energy ratio in the electrogram; and a cycle-length based metric of the electrogram.

Abstract: The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.

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 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: A uni-directional, plunger-type electrophysiology catheter handle is designed to reduce the input force a user must apply to deflect the distal end of the catheter. A force amplifier is operatively coupled to a deflection actuator of the handle. The force amplifier can be a pulley or a system of gears. The force amplifier can increase the output force of deflection actuator by the same factor as that by which the user input force is reduced. A variable-friction autolocking system can also be used to reduce the input force a user must apply during initial deflection as compared to later deflection of the catheter.