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: The present disclosure provides collapsible medical devices that may be introduced via a delivery device into a pre-existing patent foramen ovale or trans-septal puncture hole and left in place to provide both a sealing function on the atrial wall and a septal-access function for additional procedures. The disclosed medical devices include a penetrable and re-sealable gasket material disposed in an open lumen in the medical device. This penetrable and re-sealable material allows catheters or other medical devices to pass therethough for providing additional therapy to an individual. By allowing the access point or portal to be opened by a guidewire or another medical tool, the medical devices as disclosed herein may be particularly suitable for a variety of cardiac procedures including, for example, atrial fibrillation, mitral valve replacement or repair, left atrial appendage closures, and the like.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a plurality of cells including a lowermost row of cells, a valve including an inner cuff, and a plurality of leaflets secured to the stent, and an outer cuff at least partially covering the lowermost row of cells, the outer cuff having a bottom edge, a top edge, and a plurality of axially projecting arms extending from the top edge, the outer cuff being attached to at least one cell at two side vertices and a bottom vertex to form at least one parachute, and to an upper vertex of the at least one cell via at least one of the plurality of axially projecting arms.

Abstract: Described herein is a medical device for treating a target site, the medical device including, a proximal end including a disc and a distal end including a lobe. The disc and the lobe are connected by a connecting member. The lobe includes a proximal portion defining a proximal surface of the lobe, a distal portion defining a distal surface of the lobe, and a middle portion connecting and extending between the proximal portion and the distal portion. A first transition between the proximal portion and the middle portion is curved, and a second transition between the middle portion and the distal portion is curved. The medical device also includes a plurality of stabilizing wires coupled to the lobe at a radially outer surface of the middle portion, each stabilizing wire including a hook portion extending radially outward from the at least one lobe.

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 medical device for diagnosis or treatment of tissue in a body is provided. The device includes an elongate, tubular shaft configured to be received within the body. The shaft has a proximal portion and a distal portion configured for movement relative to the proximal portion. A flexible member having a predetermined stiffness is disposed between the proximal and distal portions. A plurality of coils are disposed within the shaft with one or more of the coils configured for movement with the distal portion. Electromagnetic fields generated from within or outside of the medical device induce currents in the coils from which movement of the distal portion in response to contact of the distal portion with the tissue may be determined. In one embodiment, several of the coils are connected in series to reduce the space required in the device for conductors.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent, a valve assembly, and a radiopaque element. The stent has a plurality of commissure attachment features. The valve assembly includes a plurality of leaflets and first and second cuffs. The first cuff has a proximal edge relatively close to the inflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The proximal edge of the first cuff is coupled to the proximal edge of the second cuff substantially continuously along a circumference of the inflow end of the stent so that a pocket is formed between the first cuff and the second cuff. The radiopaque element is disposed within the pocket and aligned in a longitudinal direction of the stent with at least one of the plurality of commissure attachment features.

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: The present invention generally relates to expandable catheters for use in electrophysiology, and more specifically to high-density balloon catheters for use in diagnosing and/or treating cardiac arrhythmias. A catheter includes an elongate catheter shaft comprising a proximal end and a distal end. The elongate catheter shaft defines a longitudinal axis. The catheter includes an expandable assembly having a first delivery configuration and a second deployed configuration. The balloon member includes at least one flexible framework disposed between an outer facing layer and an inner facing layer of the top surface and/or the bottom surface of the balloon member and at least one plurality of electrodes patterned onto the flexible framework. In some embodiments, a flat balloon member includes electrodes on both sides of the planar balloon member. The balloon member may include a flexible structural element disposed within the interior cavity.

Abstract: Pulmonary vein isolation has become a first-line treatment for symptomatic drug refractory atrial fibrillation (AF). In the context of PVI procedures, linear ablation lesions are delivered in order to achieve PV isolation. Electrophysiological maps from data collected by high density (HD) grid catheters can be used to identify conduction gaps associated within circumferential pulmonary vein isolation lesions.

Abstract: A patent foramen ovale (PFO) tunnel filler medical device including device anchors coupled to and extending outwardly from a filler portion of a device frame that has a generally planar shape configured to fill a PFO tunnel, and a delivery system including the same are described herein. The medical device includes a fabric layer and the device anchors are configured to extend outwardly from the device frame.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent and including a cuff and a plurality of leaflets, each leaflet being attached to adjacent commissure features and to the stent struts and/or the cuff.

Abstract: A catheter including a catheter shaft and a mapping balloon configured for navigation within a body. The mapping balloon can be coupled to the catheter shaft, such as at a distal end of the catheter shaft. The mapping balloon can have an exterior surface including a plurality of predefined fold locations configured to allow the mapping balloon to be adjusted between a collapsed configuration and an expanded configuration. In the collapsed configuration, the mapping balloon can include a first dimension, and in the expanded configuration the mapping balloon can have a second dimension. The second dimension can be greater than the first dimension. A plurality of electrodes can be located along the exterior surface of the mapping balloon to communicate electrical signals with an electronic control unit.

Abstract: A holder for a prosthetic heart valve includes a base having an annular portion defining an aperture, and a spool rotatably mated with the base. The spool has a platform and a head extending in a longitudinal direction from the platform. The holder further includes a button housing having an aperture sized and shaped to receive the head of the spool, and a button inserted in the button housing. The button housing is detachably coupled to the spool in an assembled condition. The button is movable relative to the button housing to move the button housing from a condition locked to the spool to a condition removable from the spool.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent, a cuff attached to an annulus section of the stent, and leaflets attached to the cuff between a first location and a second location distal to the first location in a flow direction. The stent may include struts shaped to form a plurality of cells connected to one another in annular rows around the stent. The cuff may have top and bottom edges and may occupy a first group of the cells, such that cells above the top edge are open cells at least partially devoid of the cuff. The cuff may have a landing zone extending at least one-third of a length of the stent in the flow direction between the bottom edge of the cuff and a proximal end of a most proximal cell of the open cells when the stent is in an expanded use condition.

Abstract: Various embodiments of the present disclosure can include a deflectable catheter shaft. The deflectable catheter shaft can include a tubular elongated body including a wall, an inner surface of which circumferentially surrounds and defines a central lumen extending a length of the tubular elongated body, the tubular elongated body extending along a longitudinal axis and comprising a body distal end and a body proximal end. The deflectable catheter shaft can include a pullwire, wherein the pullwire includes a pullwire proximal end and a pullwire distal end, and wherein the pullwire extends along the tubular elongated body. The deflectable catheter shaft can include an anchor feature coupled to the pullwire distal end, wherein the anchor feature is embedded in the wall of the body distal end.

Abstract: The present disclosure provides catheters for electroporation systems. One catheter includes a plurality of catheter electrodes disposed along a portion of a distal end of the electroporation catheter. The plurality of catheter electrodes includes a plurality of first type catheter electrodes adapted for use with an electroporation generator during an electroporation procedure and a plurality of second type catheter electrodes adapted for use with an electroporation generator during an electroporation procedure and for use with a diagnostic subsystem. The plurality of first type catheter electrodes is positioned at a distal end of the electroporation catheter. Each second type catheter electrode is adjacent another second type catheter electrode.

Abstract: The present disclosure provides collapsible medical devices that are formed from a braided tubular member configured to allow the braided tubular member to be terminated into one or more marker bands while maintaining an open lumen from a proximal end to a distal end. The collapsible medical device including the braided tubular member can be easily pulled down into a delivery sheath or other delivery device so that it is suitable for use with a number of delivery devices. The marker bands, which provide one or more attachment points for a medical device/delivery system, are positioned at one or more locations on the braid such that the braid is fixed and cannot unravel, thus preventing entanglement between individual braid wires and malformation of the device.

Abstract: Various embodiments of the present disclosure can include a medical device for providing therapy to heart tissue. The medical device can comprise a balloon, a movable manifold, wherein the movable manifold comprises a first plurality of openings and the movable manifold is inside the balloon and the movable manifold is configured to distribute a fluid within the balloon, an elongate shaft with a proximal end portion and a distal end portion, wherein the distal end portion of the elongate shaft is coupled with the balloon, a central lumen, wherein the movable manifold is movably coupled with the central lumen, and a supply lumen comprising a supply lumen proximal end and a supply lumen distal end, wherein the supply lumen is longitudinally movable and in fluid communication with the movable manifold, wherein the movable manifold is configured to move longitudinally in response to an actuation of the supply lumen proximal end.

Abstract: An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.