Abstract: The present invention relates to an anchoring device (1) designed for anchoring a prosthetic heart valve inside a heart, comprising an extraventricular part (2) designed to be positioned inside an atrium or an artery and a ventricular part (3) designed to be positioned inside a ventricle, wherein the ventricular part comprises a double wall composed of an outer wall (4) and an inner wall (5) spaced apart at the level where the prosthetic heart valve is intended to be inserted, and wherein the anchoring device further comprises a predefined V-shaped groove (8) formed between the extraventricular part (2) and the ventricular part (3). The present invention also relates to an anchoring system (11) for anchoring a prosthetic heart valve inside a heart, comprising said anchoring device (1), a prosthetic heart valve support (12) and a prosthetic heart valve (13) connected to the prosthetic heart valve support (12).

Abstract: A prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body, as well as a plurality of ventricular anchoring legs and a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body. The ventricular anchoring legs and grasping segments of the atrial anchoring arms may be configured to substantially restrict axial movement of the annular valve body within the native heart valve. In addition, anchoring segments of the atrial anchoring arms may be configured for lateral deformation relative to the native heart valve.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Abstract: A method for optimizing a shape of a replacement valve leaflet, wherein the shape of the replacement valve leaflet is determined by defining variable parameters of the replacement valve leaflet. The variable parameters may comprise: a valve height; a leaflet coaptation height, a first set of two control points for a first B-spline plane of symmetry; and a second set of two control points for a second B-spline plane tangent to a frame of the valve. The method may further comprise creating iterations of potential shapes of the replacement valve leaflet by changing one or more of the variable parameters using modeling software. The method may also comprise calculating the maximum stresses or strains on each of the potential shapes.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: An implant is coupled to first and second native leaflets of a native heart valve of a patient. The implant includes a proximal collar, a distal collar, and first and second clasps. Each of the clasps has first and second tissue-engaging portions that are (1) disposed distal to the proximal collar and proximal to the distal collar, and (2) movable, with respect to each other, to clamp one of the leaflets between the tissue-engaging portions of the clasp. The implant is configured such that, when the leaflets are clamped by the clasps, the clasps form the first and second native leaflets into a double orifice, each orifice configured to function as a respective check-valve. Fabric extends distally from the proximal collar on either side of the central longitudinal axis, and is coupled to the clasps. Other embodiments are also described.

Abstract: An implant is configured to be coupled to first and second native leaflets of a native heart valve of a patient. The implant includes a proximal collar, a distal collar, and first and second clasps. Each of the first and second clasps has first and second tissue-engaging portions that are (1) disposed distal to the proximal collar and proximal to the distal collar, (2) movable, with respect to each other, to clamp one of the leaflets between the first and second tissue-engaging portions of the clasp, and (3) movable, when clamped to the leaflet, toward and away from a central longitudinal axis of the implant. The implant includes fabric (i) extending distally from the proximal collar on either side of the central longitudinal axis, and (ii) coupled to the first and second clasps. Other embodiments are also described.

Abstract: A transcatheter valve having an expandable frame and a collapsible multi-portion skirt within the frame are provided with seams between the portions of the skirt that are located to cooperate with features of the frame and thereby reduce the exposure of the seams.

Abstract: A prosthetic mitral valve may include a collapsible stent including a plurality of struts, a plurality of cells arranged in circumferential rows, the circumferential rows including a first row at an outflow end of the stent and a second row at an inflow end of the stent, and a plurality of strut intersections where at least two of the struts connect to one another. A cuff is attached to the stent. A prosthetic valve assembly is adapted to allow blood to flow in only one direction through the valve. The prosthetic valve assembly includes a first prosthetic leaflet having a first end attached directly to a first one of the strut intersections, and a second prosthetic leaflet having a first end attached directly to the first strut intersection. The first strut intersection is partially formed of one of the struts of one of the cells in the first row.

Abstract: A loading device includes a locking collar assembly including a proximal end, a distal end, and a loading channel formed between the proximal end and the distal end. The device also includes a loading funnel coupled to the distal end of the locking collar assembly at a proximal end of the loading funnel. The loading funnel is configured to store a collapsible medical device in a partially collapsed state within a tapered interior volume of the loading funnel. The tapered interior volume decreases in volume from a distal end of the loading funnel to the proximal end of the loading funnel.

Abstract: Disclosed in the present invention are a stent apparatus having a self-pleated skirt, a processing method therefor, a skirt pleating method, and a cardiac valve. The stent apparatus comprises a stent, and is further provided with a flexible skirt. The skirt comprises: an unfolded state, where the skirt extends axially and surrounds the periphery of the stent before release; and a stacked state, where the skirt is driven by deformation during release of the stent, and gathers and is stacked along an axial direction of the released stent to form an annular perivalvular leakage blocking part. The stent apparatus is further provided with a pull-wire which is merely threaded on the skirt, and the pull-wire may react to the radial deformation during the release of the stent to drive the skirt to enter the stacked state.

Abstract: An apparatus for partially supporting a leaflet of a regurgitant heart valve comprises at least one subvalvular device including a subvalvular supporting portion including a leaflet-contacting upper supporter surface longitudinally spaced from an oppositely facing lower supporter surface. A supporter perimeter wall extends longitudinally between the upper and lower supporter surfaces, with at least a portion contacting a subvalvular cardiac wall adjacent to the heart valve. An anchor portion is adjacent to, and longitudinally spaced from, the upper supporter surface. The anchor portion includes a leaflet-contacting lower anchor surface longitudinally spaced from an oppositely facing upper anchor surface. A connector neck is interposed longitudinally between, and is directly attached to both of, the upper supporter surface and the lower anchor surface. The connector neck penetrates longitudinally through at least one of a base of the leaflet and an annulus of the heart valve at a manufactured puncture site.

Abstract: A side-deliverable 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 and configured to permit selective blood flow therethrough. The prosthetic heart valve has a compressed configuration for side-delivery to a heart of a patient via a delivery catheter. The prosthetic heart valve is configured to transition to an expanded configuration when released from the delivery catheter for seating in a native annulus. The valve frame includes distal, proximal, and septal anchoring elements, each of which is insertable through the native annulus prior to seating the prosthetic heart valve therein. The septal anchoring element is configured to extend below the annulus and contact ventricular septal tissue to stabilize the prosthetic heart valve in the annulus when the prosthetic heart valve is seated in the annulus.

Abstract: A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve includes a collapsed configuration and an expanded configuration. The transcatheter valve can further include an everted configuration and a non-everted configuration.

Abstract: A prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

Abstract: A prosthetic heart valve can include a radially collapsible and expandable annular frame having a plurality of struts defining openings. The prosthetic heart valve can further include a plurality of leaflets that regulate the flow of blood through the frame. The prosthetic heart valve can also include a sealing member mounted on the frame and having an inner layer and an outer layer. At least the outer layer is mounted on the outside of the frame, and the inner layer covers at least the openings in the frame between adjacent cusp portions of adjacent leaflets and the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood to flow through the one or more uncovered openings in the frame and into space between the outer layer and the frame.

Abstract: Prosthetic heart valves are described herein that can provide clearance to the left ventricle outflow tract (LVOT), reduce the possibility of undesirable outflow gradients, and/or limit or prevent LVOT obstructions when implanted in the heart. In some embodiments, a prosthetic heart valve can include an outer frame having a cuff portion that is disposed at an angle (e.g., 80 degrees) relative to the vertical axis of a body portion of the outer frame, so that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart. In some embodiments, a prosthetic heart valve can alternatively, or additionally, include subvalvular components having a short profile, such that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart.

Abstract: A prosthetic heart valve includes a valve frame (2), on which a plurality of valve leaflets (8) are fixed, and a fastening area for fastening in a blood vessel, which axially adjoins the valve frame (2). A stabilizing ring (14) is arranged in the fastening area. The stabilizing ring (14) defines a predetermined shape and a predetermined diameter of the fastening area and has at least one predetermined expansion point (22), whereby it is possible to expand the stabilizing ring (14) by an action of radial force on an inner circumference.

Abstract: Prosthetic heart valve apparatus is adapted for delivery into a patient in a circumferentially collapsed condition, followed by circumferential re-expansion at the implant site in the patient. The apparatus includes an annular anchoring structure that can be implanted in the patient first. The apparatus further includes an annular valve support structure, which supports a flexible leaflet structure of the valve. The support and leaflet structures are initially separate from the anchoring structure, but they can be implanted in the patient by interengagement of the support structure with the already-implanted anchoring structure.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame having an inflow end, an outflow end, and a longitudinal axis. A leaflet structure is positioned within the frame and secured thereto, and a sealing element is secured to the frame. The sealing element includes a first woven portion extending circumferentially around the frame. The first woven portion includes a plurality of interwoven filaments. The sealing element further includes a second woven portion extending circumferentially around the frame and spaced apart from the first woven portion along the longitudinal axis of the frame. At least a portion of the filaments exit the weave of the first woven portion and form loops extending radially outwardly from the frame.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance devices for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, and one or more of the following: transseptal sheath, anchor delivery catheter, implant delivery catheter, and clip delivery catheter; and methods for transcatheter implantation of a coaptation element across a heart valve.

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: A heart valve therapeutic device (1) has an elongate anchor (7) wherein the anchor has a stiffness to hold its shape and location to support the valve element. The anchor may have a stylet or a shaped or stiff collar (70) arranged to provide a desired shape to the anchor (7) and it may be lockable. A prosthetic valve element (15) has leaflets (17) and is supported on the anchor by coupler (16, 50) at a desired location. There is an actuator for changing relative axial position of the proximal and distal couplers (16, 50) on the anchor. The anchor stiffness may be sufficient to provide sufficient support to resist axial forces from the ventricle in use without necessarily having a fixing element engaging heart tissue. The prosthetic leaflets (240) may extend proximally and radially outwardly, so that there is excellent co-apting of the native leaflets (NL) against the prosthetic leaflets (240).

Abstract: A two component system for replacing mitral valves using a transcatheter approach. The first component uses a torus balloon to activate barbs into the mitral annulus after the first component stent frame has been delivered. A closed ring in the first component provides a landing site for delivery of a second component that contains replacement leaflets. The second component straddles the mitral annulus such that impingement upon the left ventricular outflow track does not occur. The second component frame contains open regions that help to prevent blood stagnation.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valves having a frame and a leaflet construct. Leaflet frame attachments for prosthetic valves include the leaflet construct being at least partially coupled to a frame outer side by a looped structure.

Abstract: Heart valve prostheses are provided for replacing a cardiac valve. The heart valve prosthesis includes a self-expanding frame including a first portion and a second portion. In the collapsed configuration, the first portion is positioned adjacent to the second portion. In the expanded configuration, the first portion moves to be positioned within an interior area of the second portion.

Abstract: Embodiments of the present disclosure provide a prosthetic heart valve usable with a heart valve delivery apparatus for delivery of the prosthetic heart valve to a native valve site via the human vasculature. In one embodiment, a self-expanding valve comprises an expandable stent that is shaped to maintain the valve in the aortic annulus against axial without anchors or retaining devices that engage the surrounding tissue. The prosthetic heart valve can have a curved shape that tapers inwardly from the inflow end to a reduced diameter section, increases in diameter from the reduced diameter section to an intermediate section, and then tapers from the intermediate section to the outflow end.

Abstract: Embodiments of an implantable prosthetic valve are disclosed. The valve can have an annular frame having a plurality of frame members and a skirt assembly. The skirt assembly can include a laminate having a fabric layer sandwiched between a first covering member and a second covering member. At least one surface of the fabric layer can be exposed at one or more windows in the second covering member. The skirt assembly can be coupled to the annular frame by a suture extending through the fabric layer at the one or more windows and around at least one of the plurality of frame members. Methods for making such an implantable prosthetic valve are also disclosed.

Abstract: Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular spacer configured for implantation with a native heart valve opening and a central valve section configured for disposal within the annular spacer. The central valve section may include at least one anchoring protrusion configured to anchor the central valve section against axial movement relative to the annular spacer. During deployment, the central valve section may be advanced downstream beyond the implanted annular spacer, and moved upstream until the anchoring protrusion engages the annular spacer.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

Abstract: A prosthetic valve has a support structure that meets with a plurality of leaflets capable of transitioning between open and closed states. The support structure can include a base frame with a polymer coating and the leaflets can be artificial. The interface between the support structure and each leaflet can be at least partially convex when viewed from an exterior of the support structure along a normal to a plane formed by a central axis of the support structure and a central axis of the leaflet.

Abstract: A driveline for an implantable blood pump including a percutaneous outer tube configured to connect with the blood pump when the blood pump is implanted within a body of a patient and an external controller outside of the body of the patient and at least one ultra-violet light emitter coupled to the outer tube.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end and a distal end. A plurality of commissure attachment features (“CAFs”) is disposed on the stent, with each CAF including a body and a plurality of eyelets. The eyelets may be arranged in a single column or in a plurality of rows and columns. The prosthetic heart valve also includes a collapsible and expandable valve assembly including a plurality of leaflets connected to the plurality of commissure attachment features. The bodies of the CAFs may include a number of other features including, for example, a slot extending between columns of eyelets.

Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.

Abstract: The invention relates to a heart implant comprising a tubular attachment element (1) for attaching an inflatable membrane (2), particularly an inflatable membrane (2) being coaxially positioned around the tubular attachment element (1) and fixed to it, the tubular attachment element (1) at one of its ends being split into several strips (4), the strips (4) extending away from the tubular attachment element (1) and forming an expandable cage (C), particularly for fixing the heart implant to the atrium of the heart by surface contact between an exterior surface of the expandable cage (C) and an interior atrium surface, each one of the strips (4) being split into two branches (4a, 4b, 4a?, 4b?, . . . ), each respective branch (4a) being merged into a new strip (5) together with another respective branch (4b?) of a neighboring strip (4) wherein such splitting and merging is performed one after the other at least three times and the number of strips (7) being formed of the last merged branches (6a, 6b, . . .

Abstract: A replacement heart valve implant defining a central longitudinal axis extending from an upstream end to a downstream end may include an expandable anchor member configured to shift between a delivery configuration and a deployed configuration, a circumferential support member distinct from and attached to the expandable anchor member, at least a portion of the circumferential support member extending downstream of the expandable anchor member, and a plurality of valve leaflets secured to the expandable anchor member. The plurality of valve leaflets may include a valve leaflet commissure movable from a first longitudinal position relative to the downstream end in the delivery configuration to a second longitudinal position relative to the downstream end in the deployed configuration.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: An expandable stent-valve has a stent component and a valve component, preferably an aortic valve component, a mitral valve component or a tricuspid valve component. The stent has, an outer surface area structured in a manner such that the surface area has a higher coefficient of friction between the outer surface and a duct wall than an untreated surface area of the stent component. The surface area is preferably structured with micro-incisions or micro-grooves.

Abstract: Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve may include an annular outer frame formed at least partially of struts intersecting at outer frame junctions and an inner frame situated within the outer frame. The inner frame may be formed at least partially of struts intersecting at inner frame junctions. The valve may include at least one inner frame tissue anchor extending from an inner frame junction. Outer frame junctions along a ventricular end of the outer frame may be angularly offset from inner frame junctions along a ventricular end of the inner frame.

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: Various embodiments of a prosthetic valve sizer and a method that utilizes such valve sizer are disclosed. In one or more embodiments, the prosthetic valve sizer can include a sizer body including an annular base and a post extending from the annular base. The prosthetic valve sizer can also include a resilient tip extending from the post of the sizer body. The resilient tip can include a material different from and more flexible than a material of the sizer body.

Abstract: A single piece stent construction having a plurality of commissure posts, each of which extends upwardly from a solid ring along a bend line and generally along a central longitudinal axis of the stent.

Abstract: A stent-valve having a valve component and a stent component for housing the valve component, as well as associated methods and systems for delivery of the stent-valve via minimally-invasive surgery. The stent-valve can be configurable between two or more configurations to assist in delivery of the stent-valve to an implantation site of a patient.

Abstract: Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

Abstract: A replacement heart valve may include a tubular anchor member actuatable between an elongated delivery configuration and an expanded deployed configuration, a buckle member fixedly attached to the anchor member, a post member axially translatable relative to the buckle member, the post member including a latch portion configured to engage the buckle member when the anchor member is in the deployed configuration, an actuator member including a pivot pin proximate a distal end thereof, the actuator member being releasably connected to a proximal end of the post member at the pivot pin, and a valve leaflet attached to the post member. The post member may be disposed distal of the anchor member when the anchor member is in the elongated delivery configuration.

Abstract: A delivery catheter for a stent. The delivery catheter may have a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further includes a handle at its proximal end and at least one sheath which may at least partially circumferentially cover the stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on the handle portion. The catheter further includes at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or the stent when observed using medical imaging during implantation of the stent.