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: A prosthetic cardiac valve implantation arrangement is described. The prosthetic cardiac valve implantation arrangement includes a prosthesis catheter with a prosthetic cardiac valve to be implanted; and an ICE catheter for introduction into area surrounding a cardiac valve to detect a relative position and/or relative direction of orientation of the cardiac valve with respect to the ICE catheter with the aid of an ultrasound image of the cardiac valve recorded by the ICE catheter. In addition, a navigation system is for determining an absolute position and an absolute direction of orientation of the ICE catheter; and a control facility is for controlling the insertion of the prosthetic cardiac valve into the annulus of the cardiac valve on the basis of the ultrasound image recordings of the ICE catheter and positional and/or orientation-direction information from the navigation system. Also described is a method for monitoring a catheter-based prosthetic cardiac valve implantation.

Abstract: A method for surgical resection planning of a mass includes the steps of, modelling the mass based on a plurality of physical dimensions, determining a plurality of safety margins around a plurality of features within the mass, simulating a resection surface on the mass that includes a plurality of triangles, optimizing local area and position of a first of the plurality of triangles on the resection surface based on a triangle-based algorithm, updating the simulation of the resection surface, and repeating the steps of optimizing and updating for each of the plurality of triangles on the resection surface.

Abstract: Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs configured to extend therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are substantially parallel to a longitudinal axis of the valve body, and a deployed configuration, in which they may deflect radially outward. The anchoring arms may include a pivoting portion configured to extend in a non-ventricular direction when the arm is in the delivery configuration and in a ventricular direction when the arm is in the deployed configuration. The entire length of each leg may be configured to extend in a non-ventricular direction when the legs are in both the delivery and deployed configurations.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to the distal end of the proximal member, the collar member comprising a base portion and one or more ribs connected to the base portion and extending distally away from the base portion. In still some additional embodiments, the guide extension catheter may further include a distal sheath member attached to the collar member, the distal sheath member having a distal diameter larger than the proximal diameter.

Abstract: A method of treating a heart of a patient is provided. The method includes implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers. Thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, tension is applied between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers. Other embodiments are also described.

Abstract: A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

Abstract: Tissue ingrowth on the distal loop portion of a constricting cord can dramatically improve the bond between the constricting cord and a cardiac valve annulus. But tissue ingrowth on the proximal portions of the constricting cord can interfere with the constricting action of the cord. This problem can be addressed by covering the proximal portions of the constricting cord with a material that resists tissue ingrowth, and waiting for tissue ingrowth to strengthen the bond between the distal loop portion of the constricting cord and the annulus. The reduced ingrowth on the proximal portions of the constricting cord make it easier to constrict the annulus when the constricting operation is eventually performed.

Abstract: The devices and methods described herein may be used to restore left ventricular function to address mitral valve regurgitation. One variation of an implant comprises a plurality of tethered anchors and a plurality of force-distribution members slidably disposed on the tether between the anchors. One or more of the force-distribution members can comprise a bioabsorbable material. Methods comprise deploying the implant to cardiac tissue, cinching the implant to its hard stop (e.g., where further cinching does not cause further tissue tightening), providing a pre-selected amount of slack to the implant after it has been cinched to its hard stop configuration, and securing a lock member on the tether. Also disclosed herein are lock member deployment catheters that provide a pre-selected amount of tether slack as it secures a lock member on the tether.

Abstract: A delivery assembly includes a sleeve that fits snugly over a main endoscope over a distal end of the endoscope. A cylindrical carrier projects distally away from the sleeve and can carry one or more resilient tissue compression rings in a stretched configuration. A push ring is slidably disposed on the carrier, and an actuator is connected to the push ring. The actuator extends through the carrier, around a distal end of the carrier, and to the push ring to connect thereto such that when the actuator is pulled proximally, the push ring is urged distally on the carrier to push at least one compression ring off the carrier, at which point the compression ring is relaxed to assume a small configuration and clamp target tissue. The actuator may include a distal segment made of a flat ribbon.

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 valve body and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. At least one ventricular anchoring leg may include a first concave portion situated between the valve body and a terminal end of the leg, and a second concave portion situated between the first concave portion and the terminal end of the leg. The first concave portion may face radially outward, while the second concave portion may face radially inward. At least one of the first concave portion and the second concave portion may be angularly aligned with a point of connection between the at least one leg and the valve body.

Abstract: An orthopedic implant has a removable handling cover coupled thereto which includes a thin-walled layer extending over a grasping portion of the outer surface. An outer container can sealingly house the orthopedic implant within a sterile environment and support the orthopedic implant in an orientation that presents the handling cover for grasping. A surgeon can manually grasp, handle and manipulate the implant into an implantation position, and remove the handling cover from the implant during implant surgery, and without the need to directly contact any surface of the orthopedic implant itself. Related methods of providing such an implant assembly and of reducing infection from contamination during implantation surgery are also disclosed.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular Compression Capable Annular Frames for a side delivered transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.

Abstract: A method for implanting a prosthesis centrally within a curved lumen includes loading a prosthesis into a delivery sheath, advancing the sheath in a patient towards the curved lumen to place at least the proximal end of the prosthesis within the curved lumen, and centering the proximal end of the prosthesis and/or the distal end of the sheath within the curved lumen. In a first advancing step, the outer catheter containing the inner sheath is advanced together towards the curved lumen to a location proximal of the curved lumen and, in a second advancing step, the inner sheath containing the prosthesis is advanced into the curved lumen to place at least the proximal end within the curved lumen while the outer catheter substantially remains at the location. After centering, the proximal end of the prosthesis is deployed centered within the curved lumen.

Abstract: A modular valve prosthesis includes an anchor stent and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the aorta and a proximal arm component extending from a proximal end of the tubular frame member and configured to be deployed in the sinuses of the aortic valve. The anchor stent further includes attachment members extending from an internal surface of the tubular frame member. The valve component includes a valve frame configured to be deployed within the tubular frame member of the anchor stent such that the valve frame engages with the attachment members of the tubular frame member and a prosthetic valve coupled to the valve frame.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent extending between an inflow end and an outflow end, and a valve assembly disposed within the stent. The prosthetic heart valve may include a supra-annular feature configured to anchor and seal the prosthetic valve above the native valve annulus and a sub-annular feature configured to anchor and seal the prosthetic valve below the native valve annulus. Each of the sub-annular feature and the supra-annular feature may be a sealing ring or a strut that extends radially outward from the stent. The prosthetic heart valve may be implanted in the patient via a sutureless approach and provide anchoring in a variety of patient populations, including those with resected native valve leaflets.

Abstract: An angioplasty apparatus and method, with a self-expanding stent, for facilitating accurate placement of the self-expanding stent for dilating a patient's blood lumen stenosis, the apparatus includes arcuate, low pressure, balloon segment(s) connected at a distal end of a deployment catheter assembly with axial gap(s) to facilitate continuous blood flow during a stenting procedure.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A method of implanting a prosthetic mitral heart valve includes advancing a guidewire through a femoral vein, an atrial septum, and a native mitral valve. A guide catheter is advanced over the guidewire and a delivery catheter is advanced through the guide catheter. A mitral valve assembly is disposed along a distal end of the delivery catheter. The mitral valve assembly includes a stent and a valve having three leaflets. The stent has a flared inlet end, an outlet end, and an intermediate portion with a plurality of prongs disposed along its outer surface. The mitral valve assembly is deployed with the flared inlet end positioned in a left atrium and the intermediate portion positioned between native mitral valve leaflets. The prongs penetrate surrounding tissue for preventing upward migration of the mitral valve assembly and the flared inlet end is shaped for preventing downward migration.

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 heart valve can include an outer frame coupled to an inner frame such that the outer frame can be moved between a first position and a second position in which the outer frame is inverted relative to the inner frame. The inner frame and the outer frame define between them an annular space, and a pocket closure can bound the annular space to form a pocket in which thrombus can form and be retained. The pocket closure can include a stretchable pocket covering that can move from a first position in which the pocket covering has a first length when the outer frame is in the first position relative to the inner frame and a second position in which the pocket covering has a second length greater than the first length when the outer frame is in the second position relative to the inner frame.

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 movable between an open position and a closed position. Each of the gripping members has a barbed portion for securing the gripping members to the native valve of a patient. Each gripping member is slidably attached to a corresponding paddle. Each gripping member can be moved in a first direction along the paddle before the barbed portion of the gripping member pierces the native valve of the patient. Each gripping member can be moved in a direction substantially opposite the first direction after the barbed portion pierces the native valve of the patient such that the gripping members create a tensioning force on the native valve of the patient.

Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: A method for replacing a cardiac valve includes an expandable support member having oppositely disposed first and second ends, a main body portion extending between the ends, and a prosthetic valve within the main body portion. The main body portion has an annular shape for expanding into position in the annulus of the valve. The first and second ends include a plurality of upper and lower wing members movable from a collapsed condition into an extended condition for respectively engaging a first section of cardiac tissue surrounding the valve and for: engaging a portion of the native valve leaflets to pin the leaflets back against the annulus. The second end further includes at least two strut members spaced apart from each other. A respective one of the strut members is attached to at least one commissural section of the prosthetic valve to prevent prolapse of the valve leaflets.

Abstract: A valve prosthesis assembly for implantation into a native valve site includes a valve prosthesis with a prosthetic valve component and a frame. The frame of the valve prosthesis includes a central portion supporting the prosthetic valve component, the central portion being configured to fit within an annulus of the native valve site, and an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site. The valve prosthesis assembly also includes a separate support flange configured to be attached to the frame after the valve prosthesis has been deployed in situ and a plurality of anchors configured to attach the support flange to the frame and configured to embed into the annulus to anchor the frame of the valve prosthesis to the native valve.

Abstract: A delivery system including a heart valve prosthesis and a delivery catheter. The delivery catheter includes an outer shaft component, an inner shaft component and a cinch mechanism. The outer shaft component has a capsule segment configured to encircle a first portion of the heart valve prosthesis and to thereby hold the first portion of the heart valve prosthesis in a reduced diameter state for delivery to a treatment site. The cinch mechanism surrounds a second portion of the heart valve prosthesis and is configured to hold the remainder of the heart valve prosthesis in a reduced diameter state for delivery to the treatment site. The capsule segment ends proximal of the cinch mechanism when the delivery catheter is in a delivery configuration. The capsule segment and the cinch mechanism in tandem hold the heart valve prosthesis in the reduced diameter state.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Abstract: A replacement heart valve assembly has a stent frame and a replacement valve. The replacement valve has a plurality of leaflets and a valve frame. The leaflets are attached to the valve frame. Further, the assembly has a plurality of suspension struts attached to the stent frame and the valve frame. The valve frame is suspended within the stent frame via the suspension struts. In some embodiments, the assembly further has a sealing member attached to the stent frame to prevent leakage around the replacement heart valve assembly.

Abstract: A delivery device for percutaneously delivering a stented prosthetic heart valve includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to the capsule. The capsule includes an expanded configuration wherein the capsule has a first outer diameter, and a collapsed configuration wherein the capsule has a second outer diameter smaller than the first outer diameter. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft. The outer stability shaft has an inner diameter, wherein the first outer diameter of the capsule is greater than the inner diameter of the outer stability shaft and the second outer diameter of the capsule is smaller than the inner diameter of the outer stability shaft.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: The present invention provides modular transcatheter valve replacement devices and methods of using the same to treat valvular heart diseases. Disclosed is a bottom module that contains a heart valve replacement, and a top module connected to the bottom module. The top module may be bio-absorbable, or may contain one or more severable joints that allow the top module to be removed after implantation. The removable or absorbable top portion serves to add additional length the structure to add in orientation during implantation, but is removed or absorbed to minimize the metal and other foreign material in a patient's body that could cause thrombosis or other reactions.

Abstract: An image-guided prosthetic valve deployment system employs a prosthetic valve (80), a catheter (70) and a delivery tracking system (90). The catheter (70) has an elongated body with a proximal tip (71a) and a distal tip (71b), and the elongated body includes a delivery section (72) adjacent the distal tip (71b) for deploying the prosthetic valve (80) relative to a heart valve (21) within an anatomical region (20). The delivery section (72) includes a delivery segment (73) for sensing a shape and an orientation of the delivery section (72) within the anatomical region (20) relative to a reference point (74). The delivery tracking system (90) tracks a position and an orientation of the prosthetic valve (80) relative to the heart valve (21) as a function of a sensed shape and a sensed orientation of the delivery section (72) within the anatomical region (20) relative to the reference point (74) by the delivery segment (73).

Abstract: A method of loading an expandable stent into a delivery device may include positioning a middle portion of the expandable stent in a collapsing fixture including a passage extending therethrough, radially compressing the middle portion of the expandable stent in the passage before any other portion of the expandable stent while a first end of the expandable stent is disposed outside of the passage, moving the collapsing fixture relative to the expandable stent, radially compressing the expandable stent from the middle portion toward the first end of the expandable stent, and inserting the first end of the expandable stent followed by the middle portion of the expandable stent into a distal end of an elongate outer sheath of the delivery device.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end and a distal end, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to at least one of the stent and a cuff. The heart valve further includes a conformable band disposed about the perimeter of the stent near the proximal end for filling gaps between the collapsible prosthetic heart valve and a native valve annulus.

Abstract: A delivery apparatus for delivering a stent-valve for implantation within the body, the delivery apparatus configured for introduction into the body through an arterial introducer of a type having a stem insertable into the body and a mouth section that remains outside the body, the mouth section including a haemostasis valve, and wherein the delivery apparatus comprises: a first constraining sheath at a stent-valve accommodation region of the apparatus at a distal end of the apparatus, and configured for constraining at least a portion of a stent-valve at the accommodation region in a radially collapsed configuration; a delivery introducer captive on the delivery apparatus, and slidable between a first position surrounding at least a portion of the stent-valve accommodation region, and a second position in which the delivery introducer slides proximally of the stent-valve accommodation region; wherein the delivery introducer is insertable at least partly into the mouth of a said arterial introducer, the deli

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Abstract: Devices and methods for delivering a sutureless valve (5) to repair a defective native valve are described herein. The devices and methods are particularly useful in minimally invasive procedures.

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 an annular main body formed by a plurality of angled struts, the main body including a plurality of peaks formed by the intersection of respective adjacent struts. The support frame further comprises one or more leaflet-engaging mechanisms configured to engage leaflets of the heart valve. The support frame can be radially expandable and collapsible.

Abstract: According to an aspect of some embodiments of the invention, there is provided a method of deploying an expandable prosthetic mitral valve in a subject, the method comprising: deploying a first component of the prosthetic mitral valve in a left atrium; deploying a second component of the prosthetic mitral valve in a left ventricle; and approximating the first and the second components so that leaflets of a native mitral valve are trapped between the first and the second components.

Abstract: Representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are disclosed. In one embodiment, for instance, a support structure and an expandable prosthetic valve are delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior) via a delivery system. The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable, prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: A delivery system and method for delivering a prosthetic heart valve to the aortic valve. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Abstract: A medical device delivery system includes an inner shaft having a proximal end and a distal end, a support shaft having a proximal end and a distal end and an articulating assembly disposed between the inner shaft and the support shaft. The support shaft is sized for insertion into the circulatory system of a patient. The articulating assembly includes a first portion extending from the distal end of the inner shaft and a second portion at the proximal end of the support shaft. The first portion is pivotable relative to the second portion to change orientation of the support shaft relative to the inner shaft. A retainer is secured to a portion of the articulating assembly and is configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft.

Abstract: A valve delivery system including a valve prosthesis, a first catheter, and a second catheter. The valve prosthesis comprises a first frame and a second frame. The first frame is configured to attach to the second frame. The first frame is releasably disposable at the distal end of the first catheter. The second catheter is slidably disposable over the first catheter. The second frame is releasably disposable at a distal end of the second catheter.

Abstract: A catheter is described for the transvascular implantation of prosthetic heart valves, e.g., including self-expanding anchorage supports, to reduce the risk to the patient during the implantation. Accordingly, a prosthetic heart valve with anchorage supports is temporarily housed in a folded form in a cartridge-type unit during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system, which includes a flexible region that can be guided through the aorta. Actuating elements run through the interior of the hollow guide system, permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle.