Abstract: In some embodiments, a medical instrument includes a flexible sheath configured to pass through the femoral artery, an inner catheter at least partially disposed within the sheath and rotatable relative thereto, the inner catheter has a deflectable section, a pair of opposing jaws coupled to the inner catheter, the pair of opposing jaws having an open condition and a closed condition, and a cutting mechanism disposed adjacent to at least one of the pair of opposing jaws.

Abstract: A prosthetic heart valve includes an outer frame, an outer sealing skirt, an inner frame, an inner sealing skirt, a plurality of prosthetic leaflets mounted within the inner frame, and a plurality of connecting arms connecting the inner frame to the outer frame so that the inner frame is positioned radially inward of the outer frame. A bridging skirt extends from the outer sealing skirt to an inflow edge of the inner sealing skirt. The bridging skirt covers a gap between the inner frame and the outer frame. The inner sealing skirt may include at least one trench that interrupts an otherwise circular shape of the inflow edge of the inner sealing skirt, the trench extending in an outflow direction of the prosthetic heart valve.

Abstract: A delivery device is configured for aligning and stabilizing a prosthetic heart valve for deployment in a native heart valve annulus. The device includes a catheter assembly having an inner shaft around which a valve compartment is defined, an outer shaft assembled over the inner shaft and adapted to slide relative to the inner shaft, a distal sheath connected to a distal end of the outer shaft and slidable therewith, an outer tube assembled over the outer shaft, and an alignment and stabilization device having a collapsed condition and an expanded condition. The outer tube is adapted to slide relative to the outer shaft to selectively cover and uncover the alignment and stabilization device.

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 for replacing a native atrioventricular valve includes a collapsible and expandable frame having atrial and ventricular portions each including a circumferential row of cells, and a center portion extending between the atrial and ventricular portion. The atrial portion and the ventricular portion may flare radially outwardly from the center portion in an expanded condition of the frame. A plurality of prosthetic leaflets may be mounted to the frame.

Abstract: A prosthetic atrioventricular valve may include a collapsible frame including an atrial disk, a ventricular disk, and a center portion between the two. The frame may include commissure attachment features (“CAFs”) that include struts extending from the center portion. Prosthetic leaflets may be mounted to the CAFs. A sealing fabric may be coupled to the frame. A commissure support ring may couple to and extend around the plurality of CAFs. The atrial disk and the ventricular disk may each flare outwardly from the center portion of the frame. The center portion of the frame may define a minimum diameter of the frame. Each of the CAFs may be spaced from adjacent ones of the CAFs so that gaps in the frame are present between adjacent ones of the CAFs.

Abstract: A flexible electronic circuit includes a plurality of leaves having a proximal section, a distal section, and an intermediate section. The plurality of leaves are bonded to each other within the distal section and loose within the intermediate section. The intermediate section also includes conductive connector pads for a wiring harness. A plurality of test connector pads are disposed on the plurality of leaves within the proximal section. The leaves within the proximal section may also be bonded to each other, for example in a ribbon or stepped configuration, in order to facilitate connection to testing apparatus. Once the circuit is tested, the proximal section can be severed from the intermediate section prior to installation of the circuit into a medical device, such as an intracardiac echocardiography catheter.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.

Abstract: A prosthetic heart valve includes a self-expanding frame, a valve assembly, and an outer cuff. A delivery device includes an inner shaft, an outer shaft, and a distal sheath disposed about a portion of the inner shaft to form a compartment with the inner shaft. The inner shaft and the distal sheath may be axially translatable relative to one another. A distal tip may be disposed at a distal end of the delivery device. In a delivery condition of the system, the distal sheath may be in a distal-most position in which the distal sheath overlies portions of the prosthetic heart valve but a distal end of the distal sheath leaves the outer cuff uncovered. In the delivery condition, a gap distance may exist between the distal end of the distal sheath and a proximal end of the distal tip, the outer cuff being positioned along the gap distance.

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 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 prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

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: The present disclosure provides an improved guidewire assembly including a sensor disposed on a distal portion thereof and a proximal connector disposed on a proximal portion thereof for electrically coupling the guidewire assembly to an external device. The proximal connector comprises at least one proximal contact and at least one reflowed insulative element disposed adjacent the at least one proximal contact.

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.