Abstract: A prosthetic heart valve may include an expandable frame with an anchoring section and a valve support section. The anchoring section may form a row of cells, two adjacent cells being joined together by a runner extending in a longitudinal direction. The anchoring section may include a plurality of commissure attachment features (“CAFs”), a first one of the CAFs features being axially aligned with the runner. Prosthetic leaflets may be mounted within the frame. A first pair of the plurality of prosthetic leaflets may be coupled together to form a first prosthetic commissure attached to the first one of the CAFs. A radiopaque marker may have a longitudinal section extending between a first end section and a second end section, and be coupled to the runner so that the longitudinal section is axially aligned with both the runner and the first one of the plurality of commissure attachment features.

Abstract: In some examples, an introducer sheath extends from a proximal end to a distal end, and includes a hub disposed at the proximal end, and a body coupled to the hub and extending between the proximal end and the distal end, the body defining a lumen and having a collapsed condition and an expanded condition, the body having a braided material and an elastomeric material covering the braided material, the body having a flared distal end.

Abstract: A catheter includes an elongate shaft, an electrode assembly, a connective stem, a coupler, a first magnetic position sensor, and a second magnetic position sensor. The electrode assembly includes microelectrodes. The connective stem includes a first connective stem member and a second connective stem member. The connective stem defines a first sensor receptacle and a second sensor receptacle in an exterior surface of the connective stem. The coupler is configured for coupling with the connective stem. The first magnetic position sensor is disposed in the first sensor receptacle and elongated along a first sensor longitudinal axis. The second magnetic position sensor disposed in the second sensor receptacle and elongated along a second sensor longitudinal axis that is not parallel to the first sensor longitudinal axis.

Abstract: A method for determining a predicted lesion size formed in a tissue by receiving or calculating a measure of contact force between the electrode and the tissue, determining a tissue characterization, and calculating the predicted lesion size using both the measure of contact force and the tissue characterization. A system comprising an electronic control unit configured to receive or determine a measure of contact force between the electrode and the tissue, characterize the tissue based on both the measure of impedance and the measure of contact force, and cause the tissue characterization to be either (a) presented to a user, or (b) applied to calculate a metric and cause the metric to be presented to the user.

Abstract: A prosthetic heart valve includes a non-collapsible annular frame extending in a longitudinal direction between an inflow edge and an outflow edge, and a valve assembly connected to the frame. The frame includes a plurality of annularly spaced commissure posts adjacent the outflow edge, each of the commissure posts including a tip and a post slot spaced apart from the tip. The prosthetic heart valve further includes a radiopaque element including an elongated main body having a first end and a second end. The radiopaque element may extend around the tip and through the post slot of at least one of the commissure posts so that a portion of the main body extends between the slot and the tip. Alternatively or additionally, a radiopaque element may be positioned adjacent a base of the frame.

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: Various embodiments of the present disclosure can include a flexible catheter tip. The flexible catheter tip can comprise an inboard understructure that defines a tip longitudinal axis, wherein the inboard understructure is formed from a first continuous element that includes a first rectangular cross-section. In some embodiments, an outboard understructure can extend along the tip longitudinal axis, wherein the outboard understructure is formed from a second continuous element that includes a second rectangular cross-section.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent, a plurality of prosthetic valve leaflets each having a belly attached to the cuff between a first location and a second location downstream of the first location in a flow direction, and a sealing structure attached to the annulus section of the stent. The annulus section of the stent may be adjacent the proximal end. The stent may include a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent. The sealing structure may have a deployed condition with a diameter greater than a diameter of the proximal end of the stent when the stent is in an expanded use 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: 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: 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: 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 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: 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 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: 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.