Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Abstract: According to one aspect of the disclosure, a method of advancing a delivery catheter to a heart of a patient includes advancing a guidewire through the vasculature of the patient until the guidewire reaches a target treatment site in or adjacent to the heart. A dilator may be positioned within the delivery catheter so that a distal tip of the dilator extends beyond a distal end of the delivery catheter. The dilator may be advanced through the vasculature of the patient directly over the guidewire while simultaneously advancing the delivery catheter through the vasculature until the distal tip of the dilator reaches the target treatment site. While maintaining the distal tip of the dilator substantially stationary relative to the target treatment site, the delivery catheter may be advanced over the dilator until the distal end of the delivery catheter is positioned at the target treatment site.

Abstract: An apical pad for securing a prosthetic heart valve within a native valve annulus. The apical pad includes an inner collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an interior surface of a heart wall, an outer collar having a collapsed condition for transcatheter delivery and an expanded condition arranged to engage an exterior of the heart wall, and a connector extending between the inner and outer collars. The inner collar is moveable relative to the outer collar to clamp the heart wall and to seal an incision extending through the heart wall.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending along a longitudinal axis and having an inflow end and an outflow end, the stent including a plurality of cells annularly arranged around the stent in at least one row, the plurality of cells having a first nesting cell adjacent the outflow end of the stent, a first engaging arm disposed within the first nesting cell and being pivotally movable between a loaded condition, a partially-released condition, and a fully-released condition, the first engaging arm and the first nesting cell having a synchronous pivoting movement, and a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets.

Abstract: A prosthetic heart valve system may include a prosthetic heart valve, a tether having a first end configured to connect to the prosthetic heart valve and a second end, and a collapsible and expandable anchor. The anchor includes a center rim configured to couple to the second end of the tether. The anchor further includes a plurality of struts extending radially outward from the center rim forming an inner dome that is concave toward a heart when the anchor is in a resting configuration implanted on an apex of the heart. The anchor further includes a plurality of wings extending radially outward from the struts.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: A loading tool for loading a collapsible prosthetic heart valve into a delivery device may include a body extending in a longitudinal direction between a proximal end and a distal end, an extension on the distal end of the body, and a slot extending through the extension from a free end of the extension toward the distal end of the body. The body may include a lumen extending between the proximal end and the distal end, the body lumen having a first diameter. The extension may have a lumen coaxial with the body lumen, the extension lumen having a second diameter less than the first diameter so as to define a shelf surface between the proximal end of the body and the free end of the extension.

Abstract: A prosthetic heart valve may include a stent, a valve assembly, a flange, and a plurality of coupling tubes. The stent may have a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows, the stent having a longitudinal axis, an inflow end and an outflow end. The valve assembly may be disposed within the stent. The flange may comprise a plurality of braided wires and may have a flared portion. The plurality of coupling tubes may couple the flange to the stent so that the flared portion is adjacent the inflow end of the stent. Each of the coupling tubes may have a first end receiving corresponding ones of the braided wires and a second end coupled to a corresponding portion of the stent.

Abstract: An implant removal device having an elongate body having a proximal end and a distal end, the elongate body being resiliently flexible and configured to transmit torque from the proximal end to the distal end with a predetermined turning ratio, and a capturing structure extending distally from the distal end and having a capture region, the capturing structure being configured to selectively center a deployed implant in relation to a longitudinal axis of the elongate body and the capture region to aid with capture and subsequent removal.

Abstract: Devices, systems and methods for removal of a mitral valve clip and subsequent delivery of a mitral valve implantation in a mitral valve replacement procedure. A modular port accessory device having a distal connector configured to be compatible with corresponding connectors on an existing therapeutic device, wherein the port accessory can be selectively attached to a proximal end portion connector of a proximal end portion of a catheter assembly of an existing therapeutic device. The catheter assembly is introduced to a target site within the patient's anatomy, and remains in place throughout a multistep therapeutic procedure for use with other therapeutic devices, all while allowing hemostasis to be controlled during use ad interchange of multiple therapeutic devices.

Abstract: A prosthetic heart valve may include a stent having an inflow end, an outflow end, a collapsed condition, and an expanded condition. The prosthetic valve may also include a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets. The prosthetic valve and/or stent may include features to anchor the prosthetic valve to a native valve annulus and to seal the prosthetic valve with respect to the native valve annulus, such as planar and/or nonplanar annular sealing members coupled to ends of the stent. The stent may include one or more circumferential rows of anchor members or hooks extending radially outwardly from the stent. These hooks may be configured to extend in a particular direction when the stent is in the collapsed condition to facilitate resheathing of the stent if, upon deployment, a user determines the prosthetic heart valve is not positioned optimally.

Abstract: A prosthetic heart valve includes stabilization features for anchoring the prosthetic heart valve within a native valve annulus. The prosthetic heart valve includes an expandable stent having an inflow end and an outflow end, and a valve assembly disposed within the stent. One such stabilization feature is a collapsible and an expandable frame formed of compliant wires. The frame has a body including a first end coupled to the stent, a second end, and a lumen extending therethrough for receiving the stent and the valve assembly. When the frame is expanded in the native valve annulus, the compliant wires form an indented region in the frame between the first and second ends of the body and a sub-annulus portion of the frame forms a bulge.

Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The anchor may include a flexible first disc biased toward a first shape that is convex in a first direction and a neck extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent having a plurality of commissure features, a plurality of first struts and a plurality of second struts. The plurality of first struts define a substantially cylindrical portion and the plurality of second struts have first ends attached to the cylindrical portion and free ends projecting radially outward from the cylindrical portion and configured to couple to adjacent heart tissue to anchor the stent. A collapsible and expandable valve assembly disposed within the stent has a plurality of leaflets coupled to the commissure features.

Abstract: A delivery device for a prosthetic mitral valve includes five sheaths and a handle. The first sheath is coupled to a first handle portion and is rotatable and bendable. The second sheath is coupled to a second handle portion and extends through the first sheath. The second sheath is bendable, rotatable and translatable relative to the first sheath. The third sheath is coupled to a third handle portion and extends through the first and second sheaths. The third sheath is translatable relative to the second sheath. The second handle portion is coupled to the first and third handle portions. The fourth sheath extends through the third sheath and forms part of a compartment to store the prosthetic valve. The fifth sheath extends through the fourth sheath to a tip and is coupled to a retaining sheath that closes the compartment to retain the valve in a collapsed condition.

Abstract: Disclosed are synthetic tissue phantoms, which mimic the properties of real human or animal tissue, and methods of manufacturing the same.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and a plurality of cells arranged in circumferential rows. The stent may include one or more securement features. One securement feature may be an anchor arm having a body portion and a free end extending from the body portion, the body portion being coupled to a perimeter of one of the plurality of cells, with the free end extending toward the inflow end in an expanded condition of the anchor arm. Another securement feature may include a flange formed of a braided mesh and having a body portion coupled to the stent and a flared portion adjacent the inflow end of the prosthetic heart valve. A valve assembly is disposed within the stent and has a plurality of leaflets.

Abstract: A loading tool for loading a collapsible prosthetic heart valve into a delivery device may include a body extending in a longitudinal direction between a proximal end and a distal end, an extension on the distal end of the body, and a slot extending through the extension from a free end of the extension toward the distal end of the body. The body may include a lumen extending between the proximal end and the distal end, the body lumen having a first diameter. The extension may have a lumen coaxial with the body lumen, the extension lumen having a second diameter less than the first diameter so as to define a shelf surface between the proximal end of the body and the free end of the extension.