Abstract: An anchoring for heart valve prostheses includes a stent framework, for attaching heart valve leaflets to an inner side, and compartmentalization clips, connected with the stent framework at a first end region and having a free second end region. The anchoring exhibits a primary form and reversibly transformable into a delivery form for the minimally invasive introduction into the body of the patient by elastic deformation and/or compression of certain regions or elements. The compartmentalization clips are arcuately shaped between the first and second end regions in the primary form and are elastically foldable such that the compartmentalization clips extend in a flat manner between the first and second end regions in the delivery form. The anchoring has a separation structure connected with the stent framework and the compartmentalization clips to separate the areas of the native leaflets to be treated from the bloodstream when the anchoring implanted.

Abstract: Methods, systems, and cooptation measurement devices as described herein include an elongate sensor body at the end of a proximal connecting member, and a plurality of sensors in an array across a face of the sensor body, wherein each sensor of the plurality of sensors is configured to detect if a portion of a heart valve is in contact with the sensor.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a method can comprise advancing a distal end portion of a delivery apparatus toward a native valve; visualizing under fluoroscopy and for a selected imaging view, a position of a radiopaque marker on the distal end portion relative to a guidewire extending through the delivery apparatus, the marker circumferentially offset from a selected commissure of the radially compressed prosthetic valve by a predetermined amount that is determined based on the selected imaging view; rotating the delivery apparatus until the marker is centered along the guidewire; and advancing the distal end portion into the native valve and inflating the balloon to radially expand and implant the prosthetic valve in the native valve such that the selected commissure is aligned with a commissure of the native valve.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a prosthetic valve. The prosthetic valve may include a jacket configured to cover at least one of gaps, spaces, or interfaces in a frame or between one or more leaflets attached to the frame.

Abstract: A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.

Abstract: An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

Abstract: Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.

Abstract: This document provides devices and methods for the treatment of heart conditions. For example, this document provides prosthetic heart valves and transcatheter heart valve replacement methods. The prosthetic heart valves can be configured into a low-profile configuration for containment within a small diameter delivery sheath. The prosthetic heart valves include can include a valve member attached to a stent frame. In some embodiments, the valve member is a molded biomaterial with a novel shape and resulting performance characteristics. Localized protective covering members can be attached to the stent frame to prevent the valve member from contacting the stent frame as the valve member cycles between its open and closed configurations.

Abstract: A replacement heart valve implant may include a tubular anchor member actuatable between a delivery and a deployed configuration, the tubular anchor member including an inflow end, an outflow end, and a plurality of anchor member intersection points, and defining a longitudinal axis extending from the inflow end to the outflow end, a plurality of valve leaflets, and a seal member secured to the tubular anchor member at the inflow end. An end surface of each of the plurality of valve leaflets may abut an inner-facing surface of the seal member. The plurality of valve leaflets each define a secured end and a free end. The secured end may be attached to the seal member adjacent the inflow end. The secured end may define the end surface, and the end surface may face toward the outflow end when the plurality of valve leaflets is in an everted position.

Abstract: A prosthetic heart valve can include an outer support assembly, an inner valve assembly, which define between them an annular space, and a pocket closure that bounds the annular space to form a pocket in which thrombus can be formed and retained. Alternatively, or additionally, the outer support assembly and the inner valve assembly can be coupled at the ventricle ends of the outer support assembly and the inner valve assembly, with the outer support assembly being relatively more compliant in hoop compression in a central, annulus portion than at the ventricle end, so that the prosthetic valve can seat securely in the annulus while imposing minimal loads on the inner valve assembly that could degrade the performance of the valve leaflets.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Abstract: A prosthetic heart valve having a cuff attached to a stent provides a seal for preventing paravalvular leakage. The cuff may be constructed from known sealing materials to fill in and around paravalvular leakage gaps, while continuously collapsing down into a low profile volume within the stent. The cuff has a first cuff portion positioned on the luminal surface of the stent and a second cuff portion. The second cuff portion has a deployed configuration in which a region of the second cuff portion is spaced from the abluminal surface of the stent and an initial configuration different from the deployed configuration.

Abstract: Apparatus is provided for use at a native atrioventricular valve of a heart of a subject. A prosthetic valve structure includes prosthetic leaflets configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure. The apparatus includes an annular portion configured to be positioned at the native atrioventricular valve and curved anchors that point in a circumferential direction around the annular portion. The anchors each having a leading tip configured to gather chordae tendineae of the heart between the anchors and the annular portion. Rotation of the prosthetic valve structure in the circumferential direction causes the anchors to gather the chordae tendineae between the anchors and the annular portion by the anchors moving, leading tip first, in the circumferential direction. Other embodiments are also described.

Abstract: A prosthetic heart valve, which may include an expandable annular outer frame having a tubular portion and at least one tissue anchor portion configured to extend from the tubular portion, may be provided. The at least one tissue anchor portion may have a plurality of attachment locations. The prosthetic heart valve may also include an expandable inner frame configured at least partially within the expandable annular outer frame. The expandable inner frame may be connected to the expandable annular outer frame solely at one or more of the plurality of attachment locations of the at least one tissue anchor portion.

Abstract: This disclosure relates generally to prosthetic valves and methods and systems for deploying, positioning, and recapturing the same. A prosthetic valve includes one or more support structures. At least one of the one or more support structures defines an elongate central passageway of the prosthetic valve. The prosthetic valve can also include a plurality of leaflet elements attached to at least one of the one or more support structures and disposed within the elongate central passageway for control of fluid flow through the elongate central passageway. At least one of the one or more support structures is configured to biodynamically fix the prosthetic valve within a native valve such as, for example, a native tricuspid valve of a heart.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stewed valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A prosthetic heart valve may include a valve assembly disposed within a stent, and first and second cuffs. The stent may extend in a longitudinal direction from an inflow end to an outflow end. The first cuff may be annularly disposed adjacent the stent. The second cuff may have a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff. The distal edge of the second cuff may be coupled to the first cuff and/or the stent at a plurality of locations to form a pocket(s) between the first and second cuffs. The proximal edge of the second cuff may be coupled to first cuff and/or to the stent at a spaced distance from the inflow end of the stent.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stewed valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

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 prosthetic heart 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 prosthetic heart 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 prosthetic heart 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 prosthetic valve is seated.

Abstract: A heart valve prosthesis including a frame, the frame including a plurality of struts designed to extend from an upstream side of a natural heart valve to a downstream side of the natural heart valve, and a plurality of connectors attached to the plurality of struts, wherein the plurality of connectors are arranged as arcs connecting the struts, the arcs having two ends, each end attached to one of the struts, and a peak pointing from a center of the frame circumferentially outward and toward the upstream side of the frame, and the plurality of connectors are arranged as at least two rows, each row circumnavigating the center lumen of the frame. Related apparatus and methods are also described.

Abstract: A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with a leaflet attachment region of a leaflet. Some embodiments include a leaflet retention feature that engages the leaflet frame projections and operates to secure the leaflet to the leaflet frame. Methods of making and using such prosthetic valve devices are also described.

Abstract: The invention relates to a transcatheter heart valve replacement (A62F2/2412), and in particular an orthogonally delivered transcatheter prosthetic valve frame having a tubular frame for mounting a flow control component wherein the valve frame is compressible to a compressed configuration for sideways or lateral introduction into the body using a delivery catheter for implanting at a desired location in the body, where the compressed configuration has a long-axis oriented roughly perpendicular to the central axis of the native annulus, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a length-wise cylindrical axis of the delivery catheter, and wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

Abstract: A valve prosthesis, an implantation device, and methods for use are provided. The devices described herein may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device can utilize movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open heart procedure includes a delivery device and a valve repair device. The valve repair device includes a pair of gripping members that are configured to attach to the native valve of the patient. A gripper control mechanism is configured to independently engage and move each of the gripping members.

Abstract: A transapically-implanted mitral valve flexible closure plate blocking body comprising: a flexible closure plate (7), a left and right guide wire (8), a guide ring (13) and a fixation plug (12). The fixation plug (12) is fixedly implanted at a cardiac apex (4) of the heart, the flexible closure plate (7) is located at an anterior and posterior leaflet junction of the heart, the left and right guide wire (8) respectively pass through a hook (6) on the same side, are fixedly connected to the flexible closure plate (7) in the upper portion on the same side, and respectively pass through a guide ring (13) fixedly connected in the lower portion of the flexible closure plate (7) on the same side, and are fixedly connected to the fixation plug (12). An implantation method thereof is also provided.

Abstract: A prosthetic valve has fluoroscopic properties for precise placement of the prosthetic valve in a human stenosed aortic orifice. The prosthetic valve comprises a support frame having a distal and a proximal end, and three adjacently placed rows of hexagonal cells (namely an upper, middle and a lower row). The upper row occupies 50-55% of total length of the support frame. The support frame of the prosthetic valve under fluoroscopy comprises a plurality of light bands and dark bands alternating with each other along the length of the support frame. Further, a second dark band from the distal end of the support frame is bisected by aortic annular plane on placement in orthotopic position of a human stenosed aortic orifice. The prosthetic valve offers advantages such as minimal protrusion in left ventricle and minimal obstruction of prosthetic valve to ostia of coronary arteries.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an annular valve body having atrial anchoring arms and ventricular anchoring legs extending therefrom. The atrial anchoring arms and the ventricular anchoring legs may be configured for independent outward radial deflection. In some embodiments, at least one atrial anchoring arm may include first and third arm segments configured to extend in upstream directions and a second arm segment configured to extend in a downstream direction, the second arm segment situated between the first and third arm segments. The terminal end of the at least one atrial anchoring arm may be configured to be situated upstream from the rest of the arm when the prosthetic valve is radially-expanded.

Abstract: An expandable prosthetic valve for implantation within a native heart valve may be provided. The prosthetic valve may include an expandable annular valve body. The valve body may include an atrial inlet opening and a ventricular outlet opening. The valve body may additionally include a plurality of tissue anchors extending from the valve body. The prosthetic valve may additionally include a flexible annular protective sleeve positioned about the rim of the valve body outlet opening and affixed to the outlet opening.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of implanting a prosthetic valve within a native heart valve may be provided. The method may include delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration. The method may also include unconstraining ventricular tissue anchors and atrial tissue anchors of the prosthetic valve while maintaining an annular valve body of the prosthetic valve in the delivery configuration. The method may also include unconstraining the annular valve body from the delivery configuration while the unconstrained atrial tissue anchors and ventricular tissue anchors are positioned within an atrium and a ventricle, respectively. Unconstraining the annular valve body may decrease a longitudinal distance between the ventricular tissue anchors and atrial tissue anchors to secure the prosthetic valve within the native heart valve.

Abstract: A prosthetic heart valve capable of being delivered via a transfemoral route as described.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A dual member stent-valve for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

Abstract: An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

Abstract: The disclosure relates to heart valve prostheses with the reduced need of pacemaker implantation and improved means for positioning the replacement heart valve.

Abstract: A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable tubular component attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the tubular component and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the tubular component into a deployed configuration that at least partially engages tissue at the native heart valve.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stewed valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: The invention relates to a prosthetic heart valve (100) for an endoprosthesis (1) used in the treatment of a stenotic cardiac valve and/or a cardiac valve insufficiency. The prosthetic heart valve (100) comprises of a plurality of leaflets (102), which consist of a natural and/or synthetic material and have a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets (102) being able to switch between their first and second position in response to the blood flow through the heart.

Abstract: The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular to a side delivered large diameter, low profile transcatheter prosthetic valve having a compressible tubular frame having a side wall and a central axial lumen, said tubular frame having a height of 8-20 mm and a diameter of 40-80 mm, an atrial sealing cuff, a subannular anchoring component, and aa flow control component comprising a leaflet structure, wherein the valve is side-delivered longitudinally to a mitral valve annulus or tricuspid valve annulus of a patient using a 22-34 Fr delivery catheter.

Abstract: A heart valve assembly has a heart valve assembly that has a wire frame comprising an anchor section, a generally cylindrical valve support section, and a neck section that transitions between the anchor section and the valve support section. The wire frame includes a plurality of supports extending radially outwardly in an annular manner about an upper end of the valve support section, and the anchor section has an annular flange that extends radially therefrom, so that an annular space is defined between the annular flange and the annular supports for receiving or capturing the native annulus when the heart valve is deployed. The heart valve assembly also includes a leaflet assembly having a plurality of leaflets that are stitched to the valve support section and which are positioned on an inflow side of the neck section.

Abstract: A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, a prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body having an atrial end, a ventricular end, and an intermediate portion between the atrial end and the ventricular end. Atrial anchoring arms and ventricular anchoring legs may extend from the intermediate portion of the valve body. At least one atrial anchoring arm may extend radially outward beyond a terminal end of at least one ventricular anchoring leg. The atrial arms and the ventricular legs may be devoid of lateral interconnections therebetween beyond locations of connection to the intermediate portion. At least one atrial anchoring arm may extend in the generally radially outward direction from a single location of connection to the intermediate portion of the valve body.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: A prosthetic heart valve can comprise a radially collapsible and expandable annular frame and a leaflet structure comprising a plurality of leaflets mounted within the frame. The frame can have commissure attachment portions that are configured to support the commissures of the leaflets in unique ways. For example, commissure attachment portions can include at least two struts defining a gap therebetween. Additionally, angularly-spaced commissure attachment portions can comprise inner struts and outer struts. Adjacent side portions of leaflets can extend through a gap between the inner struts of a corresponding commissure attachment portion. Further features and arrangements are also possible.

Abstract: A prosthetic heart valve leaflet includes a plurality of electrospun fibers at least partially embedded in a polymer matrix. The plurality of fibers includes a first polyisobutylene urethane copolymer having a first predetermined weight average percentage of hard segment portions and the polymer matrix includes a second polyisobutylene urethane copolymer having a second predetermined weight average percentage of the hard segment portions, wherein the first predetermined weight average percentage of the hard segment portions is greater than the second predetermined weight average percentage of the hard segment portions.

Abstract: A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising 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 comprises material that swells in response to contact with blood. In some embodiments, the seal comprises a flap or pocket that is distensible in response to backpressure and/or paravalve back-flow of blood.

Abstract: In one embodiment, a method of repairing a heart valve accesses an interior of a patient's beating heart minimally invasively and inserts one or more sutures into each of a plurality of heart valve leaflets with a suturing instrument. The suture ends of the sutures are divided into suture pairs, with each pair including one suture end from a suture inserted into a first valve leaflet and one suture end from a suture inserted into a second valve leaflet. One or more tourniquet tubes is advanced over the suture pairs to the leaflets to draw the sutures together to coapt the leaflets and then the sutures are secured in that position.

Abstract: A dual member stent-valve for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.