Abstract: In some examples, an expandable introducer sheath includes an clastic outer layer, and a liner disposed within the clastic outer layer and defining a lumen, the liner being capable of transitioning between a folded collapsed condition, and a star-shaped expanded condition.

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: Techniques are provided for candidate screening for a target therapy. A plurality of medical codes corresponding to patient billing data are identified. A candidate classification model for a target therapy is generated by selecting a set of medical codes from the plurality of medical codes and assigning a weight to each medical code selected. The candidate classification model is applied to patient billing data for a plurality of patients to generate a set of target therapy scores. The patient billing data includes associations between one or more patients of the plurality of patients and one or more medical codes of the plurality of medical codes. Each target therapy score corresponds to a patient of the plurality of patients, and is calculated based on weights for one or more medical codes associated with the patient.

Abstract: Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial fibrillation.

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 delivery system for delivering a medical device may include a handle, a delivery catheter extending distally from the handle, and a balloon mounted to a distal end portion of the delivery catheter. An actuator on the handle may be operably coupled to the delivery catheter such that actuation of the actuator applies a torque on a proximal end portion of the delivery catheter. The delivery catheter may have a proximal segment formed of a first material and the delivery catheter may have a distal segment formed of a second material, the first material being stiffer than the second material, and the proximal segment being stiffer than the distal segment.

Abstract: A prosthetic valve delivery system may include a handle, an inner catheter extending through an outer catheter, a nosecone attached to the inner catheter, and a balloon. The balloon may have a proximal portion fixed to the outer catheter, a distal portion fixed to either the nosecone or the inner catheter, and a center portion. A prosthetic heart valve may be configured to be received over the center portion of the balloon. A steering wire may have a proximal end operably coupled to the handle and a distal end coupled to the steering ring to form a deflection point, the deflection point being positioned distal to a point at which the proximal portion of the balloon is fixed to the distal end portion of the outer catheter.

Abstract: A prosthetic heart valve delivery system may include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal end portion of the outer catheter. A prosthetic heart valve may be configured to be received over the balloon, and a balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon segment and a distal balloon segment positioned distal to the proximal balloon segment. An interior volume of the proximal balloon segment may be fluidly isolated from an interior volume of the distal balloon segment so that the proximal balloon segment and the distal balloon segment may be inflated independently of each other.

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: In some examples, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, each of the plurality of commissure attachment features including a generally rectangular body having a top strut, a bottom strut and two sides struts, and defining a central aperture, a valve assembly comprising a cuff and a plurality of leaflets, and a plurality of commissure regions, each of the plurality of commissure regions including a fabric folded over the top strut of one of the plurality of commissure attachment features to form an inner fabric layer and an outer fabric layer, and one or more sutures coupling the inner fabric layer and the outer fabric layer via the central aperture.

Abstract: Flexible high-density mapping catheter tips and flexible ablation catheter tips with onboard high-density mapping electrodes are disclosed. These tips can be used for diagnosing and treating cardiac arrhythmias. The flexible, distal tips are adapted to conform to tissue and comprise a plurality of microelectrodes mounted to permit relative movement among at least some of the microelectrodes. The flexible tip portions may comprise a flexible framework forming a flexible array of microelectrodes (for example, a planar or cylindrical array) adapted to conform to tissue and constructed at least in part from nonconductive material in some embodiments. The flexible array of microelectrodes may be formed from a plurality of rows of longitudinally-aligned microelectrodes. The flexible array may further comprise, for example, a plurality of electrode-carrying arms or electrode-carrier bands. Multiple flexible frameworks may be present on a single device.

Abstract: Various embodiments of the present disclosure can include a high-density electrode catheter. In some embodiments, the high-density electrode catheter can include a catheter shaft including a proximal end and a distal end, the catheter shaft defining a catheter shaft longitudinal axis. In some embodiments, the high-density electrode catheter can include a shaft magnetic position sensor disposed along a distal portion of the catheter shaft. In some embodiments, the high-density electrode catheter can include a flexible tip portion located adjacent to the distal end of the catheter shaft, wherein the flexible tip portion includes a flexible framework. In some embodiments, the high-density electrode catheter can include a plurality of electrodes disposed on the flexible framework. In some embodiments, the high-density electrode catheter can include a tip magnetic position sensor disposed on a portion of the flexible framework.

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: A delivery device includes a handle having an interior mounting shaft, a catheter sheath extending distally from the handle, and a sheath hub coupled to the catheter sheath, the sheath hub having a body including at least one of a keyed feature for preventing rotation of the sheath hub relative to the handle, and a snap feature for preventing translation of the sheath hub relative to the handle.

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, and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, each of the plurality leaflets having two leaflet attachment regions, the leaflet attachment regions being folded adjacent the plurality of commissure attachment features.

Abstract: A prosthetic heart valve may include a balloon-expandable frame extending between an inflow end and an outflow end, a plurality of prosthetic leaflets mounted within the frame, and an inner skirt positioned between the plurality of prosthetic leaflets and the frame. The frame may include a first row of diamond-shaped cells at the inflow end of the frame, a second row of diamond-shaped cells, and a row of outflow cells positioned at the outflow end of the frame. Each cell in the row of outflow cells may not be diamond-shaped, and, in an expanded condition of the frame, each cell in the row of outflow cells may have a larger area than that of each cell in the first and second rows of diamond-shaped cells. Each outflow cell may be at least partially defined by a commissure attachment feature, and each outflow cell may lack symmetry.

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 delivery device for delivering a prosthetic heart valve may include a balloon catheter shaft having a distal end, an inner shaft extending through the balloon catheter in a proximal-to-distal direction, an atraumatic distal tip positioned at a distal end of the inner shaft, and a balloon positioned between the distal end of the balloon catheter shaft and the atraumatic distal tip. In an uninflated condition of the balloon, the balloon may include a proximal bulge, a distal bulge, and an intermediate section having a diameter that is smaller than a diameter of the proximal bulge and smaller than a diameter of the distal bulge. The distal bulge may extend a first length in the proximal-to-distal direction, and the proximal bulge may extend a second length in the proximal-to-distal direction, the first length being different than the second length.

Abstract: The instant disclosure relates to electrophysiology catheters for tissue ablation within a cardiac muscle. In particular, the instant disclosure relates to an electrophysiology catheter that conforms to a shape of a pulmonary vein receiving ablation therapy for a cardiac arrhythmia and produces a consistent tissue ablation line along a length and circumference of the pulmonary venous tissue.

Abstract: Braided occluding devices having an access passage and methods including the same are described herein. The occluding device includes a braided frame. The braided frame includes an annular distal disc portion, a waist member, and an annular proximal disc portion defining a passageway through the braided frame. The braided frame is formed with a closed end braid.