Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

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 valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the valve to be delivered to a heart of a patient via a delivery catheter. The valve frame is configured to transition to an expanded configuration when released from the delivery catheter. The valve is configured to be seated in a native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements configured to be inserted through the native annulus prior to seating the valve. The proximal anchoring element is ready to be deployed subannularly or is optionally configured to be transitioned from a first configuration to a second configuration after the valve is seated.

Abstract: A prosthetic heart valve (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion and a ring portion that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient's tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame defines a central channel that extends along a central axis. The flow control component is disposed within the central channel and coupled to the outer frame. The flow control component has a set of leaflets mounted within an inner frame. The prosthetic valve is configured to be folded along a longitudinal axis and compressed along the central axis to place the prosthetic valve in a compressed configuration for delivery via a delivery catheter. The longitudinal axis is substantially parallel to a lengthwise axis of the delivery catheter when disposed therein. The prosthetic valve transitions to an expanded configuration when released from the delivery catheter. The flow control component elastically deforms from a substantially cylindrical configuration to a substantially flattened configuration when the prosthetic valve is placed in the compressed configuration.

Abstract: Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

Abstract: In certain embodiments, a multiple component heart valve prosthesis includes an abutment ring and a removable bioprosthetic heart valve. The abutment ring is configured for attachment at a heart valve annulus location and includes a locking system. The removable bioprosthetic heart valve includes a valve frame and at least one locking feature. The at least one locking feature is configured to be received by the locking system. The bioprosthetic heart valve can be rotated relative to the abutment ring such that the at least one locking feature transitions from a disengaged position to a first engaged position. When in the disengaged position the bioprosthetic heart valve may be removed from the abutment ring, and when rotated to the engaged position the bioprosthetic heart valve is restrained from axial movement relative to the abutment ring.

Abstract: The present invention concerns a prosthetic heart valve for supporting or replacing a non- or malfunctioning native heart valve, the prosthetic heart valve comprising an expandable generally tubular stent support, having an inner surface and an outer surface, and comprising a valve element, having an outer surface, an inner surface, and comprising a plurality of sealing elements, wherein the sealing elements are—spaced apart from one another—circumferentially attached to the outer surface of the valve element and form a lip-shaped element radially protruding from the outer surface of the valve element, wherein the valve element is mounted on the inner surface of the stent support.

Abstract: A side-deliverable prosthetic valve includes an outer frame, a flow control component mounted within the outer frame, and an anchoring element coupled to a distal side of the outer frame. The prosthetic valve is foldable along a longitudinal axis and compressible along a central axis to a compressed configuration for side delivery via a delivery catheter and is expandable to an expanded configuration when released from the delivery catheter. An end portion of the anchoring element is configured to engage a guide wire. The anchoring element is extended during deployment to allow the anchoring element to capture at least one of native leaflet or chordae and, in response to the guide wire being disengaged from the end portion, transitions to a folded configuration to secure at least one of the native leaflet or the chordae between the anchoring element and the distal side of the outer frame.

Abstract: Disclosed herein are various embodiments directed to a device for minimally invasive medical treatment. The device being a hollow tube with a first end, a second end, and one or more anchors configured to extend outward from the exterior of the hollow tube. The hollow tube having a plurality of cutouts on the exterior, wherein the cutouts allow the hollow tube to be flexible. Additionally, the hollow tube may have at least one snap mechanism configured to connect the first end and the second end together.

Abstract: A prosthetic heart valve is disclosed that is deformable between collapsed, radially uncompressed, and target conditions. The prosthetic heart valve includes an inner frame, at least one leaflet, and a braided wire mesh arranged outside and coupled to the inner frame by a coupling portion. The braided wire mesh includes a body portion between the coupling portion and a flared portion. In the radially uncompressed condition, the prosthetic heart valve forms a cavity surrounded by the braided wire mesh and the inner frame. In the target condition, only a part of the length of the body portion is radially compressed along an axis extending from an upstream side to a downstream side. In the collapsed condition, the inner frame and braided wire mesh are radially collapsed over their entire length. In the radially uncompressed condition, the body portion is tubular and the braided wire mesh has a rotationally symmetric circumference.

Abstract: This disclosure is directed to prosthetic heart valves having elongated sealing members. As one example, a prosthetic heart valve comprises an annular frame, a leaflet assembly comprising a plurality of leaflets, and a skirt assembly comprising an inner skirt, an outer skirt, and/or a third skirt. The frame is radially compressible and expandable between a radially compressed state and a radially expanded state and comprises a plurality of apices at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates extra space between the inflow end of the frame and the skirt assembly when the frame is in the radially expanded state. This pocket allows the apices at the inflow end of the frame to move towards an inflow end of the pocket when the frame is radially compressed to the radially compressed state without protruding through the skirt assembly.

Abstract: A protection and loading device for an interventional valve system is provided. The interventional valve system includes a valve and a delivery system. The valve is fixed on a distal rod body of the delivery system. The protection and loading device includes: a first protector, a second protector, and a third protector. The first protector is located at a front end of the distal rod body and encompasses a half of the valve. The third protector is configured to fix and sleeve on the distal rod body. In a protection state, the first protector cooperates with the third protector at the first position. In a state of valve loading the first protector cooperates with the third protector at the second position.

Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: A left atrial appendage (LAA) occluder and an LAA occlusion system are disclosed. The LAA occluder enables an increased surgical success rate by allowing repeated good positioning, retrieval and release of the occluder and avoiding the problem of entanglement of the occluding stent during surgery. The LAA occluder includes an occluding stent, a proximal securing member a distal securing member. The occluding stent includes an occlusion structure and a traction structure. The delivery device includes a hollow push tube and a control shaft. The distal securing member can be driven by the control shaft to move toward the proximal securing member until a first distal end of the occlusion structure is in a collapsed configuration, where the distal securing member is blocked from further movement, avoiding the problem of entanglement arising from inward rolling of the occluding stent in the vent of human error.

Abstract: A partial valve prosthesis includes a framework configured for following a shape of a portion of the native valve annulus when implanted into the native valve annulus, the framework including securement features for anchoring the framework to an inner periphery of the native valve annulus and retaining at least one leaflet configured to replace a corresponding one of the plurality of native leaflets; and at least one leaflet secured to the framework. Additional embodiments and methods are disclosed.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are moveable between an open position and a closed position. The gripping members can have different configurations for effective attachment and release from the native valve of the patient.

Abstract: Prosthetic valve systems for treating a native valve exhibiting regurgitation can include a support structure in which a separate prosthetic heart valve can be placed. A method for implant a prosthetic valve system can include advancing a first catheter delivery sheath through an introducer sheath and into a left ventricle of a patient's heart, deploying at least a portion of a support structure from the first catheter delivery sheath and positioning the support structure around native leaflets of the patient's native mitral valve, positioning a prosthetic heart valve in a radially collapsed configuration within the patient's native mitral valve, and expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein the prosthetic heart valve contacts the native leaflets from within the patient's native mitral valve and is separated from the support structure by the native leaflets.

Abstract: A method includes advancing a delivery assembly through a patient's vasculature toward a native heart valve of the patient, wherein the delivery assembly comprises a first catheter assembly and a second catheter assembly extending through a shaft of the first catheter assembly, and wherein a support member is in an uncoiled, elongated configuration within a sheath of the first catheter assembly. The support member is deployed from the sheath by pushing the second catheter assembly distally relative to the first catheter assembly so that the support member is uncovered by the sheath and the support member extends around native chordae tendineae and native leaflets of the native heart valve. A prosthetic valve is implanted within the native leaflets of the native heart valve such that the native leaflets are frictionally engaged between the support member and the prosthetic valve.

Abstract: A ring sizer including a face plate that has markings usable to provide measurements of a valve. The sizer may include a clear face plate on which the markings are provided such that the valve is visible through the face plate facilitating accurate measurements of various valve dimensions and optimal ring sizing.

Abstract: A transcatheter prosthetic heart valve includes a stent frame and at least one sheet of leaflet material formed in to a tube, which includes a lower portion disposed on an exterior of the stent frame and an upper edge portion disposed within the stent frame. The upper edge portion includes at least a portion configured to wrap around a first portion of the top edge of the stent frame and fold towards an exterior of the stent frame. The upper edge portion also includes at least another portion configured to weave through the stent frame and fold towards the interior of the stent frame.

Abstract: Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology.

Abstract: A prosthetic heart valve includes a frame, a valvular structure, and a skirt. The frame is movable between collapsed and expanded configurations and includes struts disposed between inflow and outflow ends, apices disposed at the inflow end formed by intersections of two or more struts, and junctions disposed between the apices and the outflow end and formed by intersections of two or more struts. The apices are circumferentially offset from the junctions. The valvular structure is positioned within and secured to the frame. The skirt is secured to the frame and includes a first edge portion and a second edge portion. The first edge portion is secured to the frame at the apices. The second edge portion is secured to the frame at the junctions. The skirt is configured to retract inwardly between the apices when the frame is moved from the radially expanded configuration to the radially collapsed configuration.

Abstract: Novel tools and techniques are provided for implementing protection of at least one tissue layer of a medical device or implant during crimping of the medical device or implant. In various embodiments, an implant tissue protection tool may include an outer portion configured to surround one or more outer segments of at least one tissue layer of a medical device to be implanted into a body of a subject and at least one protrusion (which may be affixed to a surface of the outer portion) configured to minimize or prevent occurrence (or likelihood of occurrence) of the at least one tissue layer (in some cases, leaflet material, or the like) of the medical device passing through at least one opening defined by a frame structure of the medical device during crimping of the medical device by a crimping device in preparation for implantation into the body of the subject.

Abstract: The present application relates to a transcatheter prosthetic valve replacement system including a delivery catheter, a frame, a prosthetic valve, and one or more clamping devices. The prosthetic valve is fixed in the frame. The clamping device is connected to a periphery of the frame. The frame and the clamping device can be preloaded in the delivery catheter. The clamping device includes a clamping member, a collar, and a control member. One end of the clamping member is a fixation end which is fixedly connected to the frame, and the other end of the clamping member is a deployable resilient segment which can be compressed and released. The collar is slidably sleeved on the clamping member. One end of the control member is connected to the collar, and the other end of the control member is manipulated outside the body. From being compressed to being fully released, the clamping member in sequence has two configurations.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Abstract: The present invention provides a prosthetic heart valve device with improved fit and/or apposition between the device frame and left atrial tissue and/or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and/or mitigate paravalvular leakage. The improved fit and/or apposition arises in various embodiments by providing or allowing an asymmetrical frame and/or frame base and/or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and/or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

Abstract: An assembly-type device for the treatment of tricuspid regurgitation is proposed. The assembly-type device includes: a fixing member for the pulmonary artery, the fixing member installed in the pulmonary artery; a connecting tube provided with a connecting tube lumen formed therein to be movable along a connecting wire; an assembly part provided with a first assembly coupled to a lower end of the fixing member for the pulmonary artery and a second assembly coupled to an upper end of the connecting tube, wherein the fixing member for the pulmonary artery and the connecting tube are assembled together; a fixing member for inferior vena cava, the fixing member coupled to a lower end of the connecting tube and installed in the inferior vena cava; and a blocking part coupled to one side of the connecting tube and obliquely passing through a tricuspid valve to block an orifice of the tricuspid valve.

Abstract: Apparatus and methods are described including a valve frame (20) configured to support a prosthetic valve within a native atrio-ventricular valve. The valve frame (20) includes an atrial part (26) and a cylindrical part (22), to which the prosthetic valve leaflets (23) are coupled. A plurality of chord-recruiting arms (24) extend at least radially from the ventricular end of the cylindrical part (22). The chord-recruiting arms (24) are coupled to the ventricular end of the cylindrical part via stitches (82), and the stitches (82) are configured to act as hinges, such that upon being released from a radially-constrained configuration, while the cylindrical part (22) is held in an at least partially radially-constrained configuration, the chord-recruiting arms (24) are configured to extend radially outwardly by pivoting about the stitches (82) with respect to the cylindrical part (22). Other applications are also described.

Abstract: A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.

Abstract: An articulating implant holder system for heart valve repair or replacement has an implant configured to be secured to a heart valve annulus, an implant holder secured to the implant, an articulating handle assembly comprising a handle, a swivel pivotably secured to the handle at a first location and a connector pivotably secured to the swivel at a second location, an actuating cable secured between the handle and the connector to cause the swivel to move from a first position to a second position, and a latch removably secured to the implant holder. A plurality of sizer heads are configured to correspond to different sizes of heart valve annuluses and each of the plurality of sizer heads has a latching feature. A latching feature of the swivel is configured to removably snap on to the latching feature of each of the plurality of sizer heads and is configured to permanently snap on to the latch.

Abstract: The disclosure generally relates to delivery devices for transcatheter delivery of a prosthesis. The delivery device includes a hollow shaft on which the prosthesis is supported. A handle assembly maintains the shaft. The delivery device further includes a guide wire that is selectively directed through the handle assembly and shaft. The guide wire directs the shaft to a target site at which the prosthesis is to be deployed. In practice, an operator managing the inner catheter controls the prosthesis positioning. The delivery devices disclosed herein are configured to ergonomically also allow the operator to control the position of the guide wire as the position of the guide wire influences the deployment position of the prosthesis. In this way, a second operator for positioning the guide wire can be omitted. Embodiments of the disclosure are believed to improve positioning predictability and ease of use.

Abstract: Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

Abstract: Excessive dilation of the annulus of a mitral valve may lead to regurgitation of blood during ventricular contraction. This regurgitation may lead to a reduction in cardiac output. Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The implant may then contract to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the mitral valve and lessening any of the associated symptoms including mitral regurgitation.

Abstract: An example system for delivering an implantable heart valve is disclosed. The system includes an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a first aperture. The system also includes a support shaft having a proximal end region, a distal end region and a second coupling member disposed along a portion of the proximal end region, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The system also includes a locking clip coupled to the inner shaft, wherein coupling the inner shaft to the support shaft includes extending at least a portion of the locking clip through the first aperture and into at least a portion of the groove.

Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member. The device further includes an extension member coupled to the anchoring member and having an annular first portion coupled to the anchoring member and a second portion coupled to the first portion. The extension member is folded in a delivery configuration such that the first portion overlaps the second portion. When released from the a delivery catheter, the extension member unfolds such that the first portion extends radially outwardly from the anchoring member and the second portion extends radially outwardly from the first portion.

Abstract: A procedure for placing a cardiac valve includes cutting leaflets of another cardiac valve, expanding the cardiac valve, applying a downward pushing force to the expanded cardiac valve, and inverting the cut leaflets of the other cardiac valve toward a ventricle. The cardiac valve includes a self-expanding frame, vertical posts coupled to the self-expanding frame, and valve leaflets coupled to the self-expanding frame or to the vertical posts. Each of the vertical posts includes a connection to a corresponding control wire.

Abstract: A stent-graft prosthesis includes a graft material having a tubular construction, a frame coupled to the graft material, and a port or opening disposed between a proximal end and a distal end of the graft material. The port or opening is open during deployment of the stent-graft prosthesis to enable blood flow from a graft lumen within the graft material to exit the graft lumen, and the port or opening is blocked upon full deployment of the stent-graft prosthesis to prevent blood flow from within the graft lumen from exiting the graft lumen through the port or opening.

Abstract: The disclosure relates to a holder (1) for a heart valve prosthesis (100) including a radially contractible armature (102) and a prosthetic valve carried by said armature (102). The holder (1) includes an annular member (2) having a longitudinal axis (xl) and comprising a plurality of supporting formations (3), said supporting formations (3) protruding radially inwardly of said annular member (2), and a locking member (4) configured for coupling with said annular member (2). Each supporting formation (3) includes a coupling profile or feature (9) configured for engaging the armature (102) of a heart valve prosthesis (100). The coupling profile or feature (9) being configured to prevent the displacement of the armature (102) along said longitudinal axis and being configured to prevent rotation of the armature (102) around the longitudinal axis (X1), while leaving the armature (102) unconstrained in a radially inward direction.

Abstract: Embodiments hereof relate methods of delivering a valve prosthesis to an annulus of a native valve of a heart. A valve delivery system is introduced into a ventricle of the heart via a ventricular wall of the heart. The valve delivery system has a displacement component at the distal portion thereof. The valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has a first outer diameter. While the valve prosthesis is in the delivery configuration, the displacement component of the valve delivery system is radially expanded into an expanded state in which the displacement component has a second outer diameter greater than the first outer diameter. The valve delivery system is advanced towards the annulus of the native valve of the heart with the displacement component in the expanded state to displace chordae tendineae.

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 transcatheter valve prosthesis is disclosed that has a compressed, delivery configuration and an expanded configuration for deployment within a native heart valve. The valve prosthesis includes a self-expanding frame and a prosthetic valve component. The self-expanding frame includes a valve receiving portion defining an opening therethrough and first and second anchors at opposing ends of the valve receiving portion. The valve receiving portion is substantially planar and the first and second anchors are oriented substantially perpendicular to the valve receiving portion when the valve prosthesis is in the expanded configuration. The prosthetic valve component is disposed within the opening of the valve receiving portion and secured thereto.

Abstract: A holder for a hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a non-expandable, non-compressible prosthetic valve and a self-expandable anchoring stent, thereby enabling attachment to the annulus without sutures. A first suture connects the holder to the valve and constricts an inflow end of the anchoring stent. A second suture connects the holder to the valve and extends down three holder legs to loop through fabric on the valve. Both sutures may loop over a single cutting well on the holder so that severing the first and second sutures at the single cutting well simultaneously releases the tension in the first suture, permitting the inflow end of the anchoring stent to expand, and disconnects the valve holder from the prosthetic heart valve.

Abstract: The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.

Abstract: Prosthetic heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, an anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. One or more arms attached to the frame of the valve guide the anchoring device into position at the native valve as it exits the delivery catheter, and the expandable prosthetic valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

Abstract: A heart valve annulus repair device having a tissue engaging member and a plurality of anchors. The tissue engaging member includes a loop of wire. Each of the anchors has a pointy front end and a back end and a slot that runs in a front-to-back direction. The anchors are distributed about the loop of wire with the front ends of the plurality of anchors facing the heart valve annulus and with the loop of wire passing through the slots. The device further includes means for implanting the anchors into the heart valve annulus tissue so that the tissue engaging member becomes affixed to the heart valve annulus.

Abstract: Methods for rotationally aligning transcatheter heart valve prosthesis within a native heart valve include percutaneously delivering the transcatheter heart valve prosthesis to the native heart valve, wherein the transcatheter heart valve prosthesis includes at least one imaging marker, receiving a cusp overlap viewing angle image and/or a coronary overlap viewing angle image of the transcatheter heart valve prosthesis within the native heart valve, determining, based on the cusp overlap viewing angle image and/or the coronary overlap viewing angle image and the at least one imaging marker, whether the transcatheter heart valve prosthesis is in a desired rotational orientation, if the at least one imaging marker in the cusp overlap viewing angle image and/or the coronary overlap viewing angle indicates that the transcatheter heart valve prosthesis is not in the desired rotational orientation, rotating the transcatheter heart valve prosthesis until the transcatheter heart valve prosthesis is in the desired rot

Abstract: Systems and methods of fluid passageway cross-sectional area determination in an anatomy are disclosed.