Abstract: A radially expandable prosthetic valve can comprise an annular frame, at least one expansion mechanism and a cord. The annular frame can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The expansion mechanism can comprise a first member attached to the frame at a first location and a second member attached to the frame at a second location axially spaced from the first location. The cord can extend at least partially along the expansion mechanism in a first direction, be reeved around a portion of the second member, and extend at least partially along the expansion mechanism in a second direction opposite the first direction. Applying a proximally directed force to a first portion of the cord can cause the second member to move relative to the first member, which can cause the frame to foreshorten axially and expand radially.

Abstract: Anchor devices and methods used to secure a prosthetic valve to a native valve annulus are described. The anchor device can be a separate expandable element from the prosthetic valve that is first advanced to the annulus and deployed, after which an expandable prosthetic valve is advanced to within the annulus and deployed. The combination of the two elements can apply a clamping force to the valve leaflets which holds the prosthetic valve in place. The anchor device can have a lower or ventricular portion and an upper or atrial portion. The anchor device can include one or more leaflet clamping portions. One, two, or more upstanding vertical posts between the clamping portions can extend upward at the valve commissures and support the upper portion, which can include one or more structures for leak prevention.

Abstract: A catheter system for implant delivery is provided. The delivery system includes a primary rotary knob and a secondary rotary knob. The primary rotary knob moves a catheter shaft to load or unload an implant whereas the secondary rotary knob is connected to an inner shaft. The inner shaft comprises an implant holder to engage with the implant during loading and unloading. The movement of the inner shaft due to rotation of the secondary rotary knob improves positioning of the implant and ensures detachment of the implant from the implant holder due to micro movements of the implant holder.

Abstract: Aspects of the disclosure are generally related to systems, devices and methods for transcatheter delivery and deployment of an implant, such as a prosthetic valve. Aspects of the disclosure include methods of loading the implant to the delivery device having a capsule assembly for sheathing the implant. The capsule assembly can include separable proximal and distal segments. Such methods of loading can include utilizing a collar and a funnel to guide the proximal segment over the implant and adjacent the distal segment to compress and fully sheathe the implant for delivery.

Abstract: Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

Abstract: A method of delivering and deploying a valve prosthesis includes delivering the valve prosthesis disposed in a delivery catheter to a native valve, proximally retracting a delivery catheter tube of the delivery catheter such that three engagement arms of a support of the valve prosthesis are released from the delivery catheter tube and flare outwardly while an inflow frame portion of the support remains within a distal portion of the delivery catheter, and distally advancing the distal portion of the delivery catheter such that the inflow frame portion is released from the distal portion.

Abstract: Apparatus for repairing a leaflet of a heart valve can include a leaflet-plicating tool that can include leaflet-capture arms and a helical needle. The needle can be operatively coupled to the leaflet-capture arms. The leaflet-capture arms can include an arm-shaft, each configured to house a leaflet-engaging member. The leaflet-capture arms can be configured to use the leaflet-engaging members, extended over the leaflet from the annulus toward a free edge of the leaflet, to form a plication in the leaflet of the heart valve between the leaflet-capture arms. The leaflet-plicating tool can be configured to secure the plication by using the helical needle to stitch a suture helically along the plication. Other embodiments are also described.

Abstract: There is provided a method of treating a patient, comprising: delivering a self-expandable transcatheter heart valve (THV) over a guidewire in a contracted state and within a sheath to a first anatomical location within a heart of the patient, moving the THV relative to the sheath for partially self-expanding a portion of the THV within the first anatomical location, wherein a portion of the THV in the sheath remains in the contracted state and the THV is partially self-expanded, and refraining from moving the partially self-expanded THV, relative to the aortic annulus of the heart.

Abstract: Valvular implants and blood vessel closure devices herein are configured to be positioned in the heart and to block regurgitant blood flow from the heart into blood vessels supplying blood to the heart. The valvular implants can have a cover, a membrane, a valve, a resilient frame, and/or other features. Some valvular implants can have anchors to be positioned in the blood vessels, such as in pulmonary veins, and can anchor the implant to the heart wall. Various embodiments of covers and/or membranes act as valves contracting and expanding, to alternately permit and block blood flow. The valvular implants can cover one or more blood vessels, such as one, two, three, or four pulmonary veins, and can also be configured and implanted to block an appendage to the heart, such as the left atrial appendage.

Abstract: A method of repairing a defective heart valve is disclosed comprising directing an implant delivery catheter to form a first curve of the implant delivery catheter around chordae of the heart valve on a ventricular side of the heart valve, inserting the implant delivery catheter through the heart valve to an atrial side thereof, forming a second curve of the delivery catheter along an annulus of the heart valve on the atrial side, and ejecting an annuloplasty implant from the delivery catheter while retracting the delivery catheter such that the annuloplasty implant is arranged along the first and second curve on the ventricular and atrial side.

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: An implantable device includes an adjustable spacer and at least one anchor. The adjustable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween. The adjustable spacer can comprise a first side and a second side opposite the first side. Each side can be adjustable between a first width and a second width. Each side can be independently moved between the first width and the second width. The adjustable spacer can be made from a sponge material.

Abstract: The application provides a valve clamping system. The valve clamping system includes a pushing device and a valve clip with coatings. The valve clip includes a push rod, the coatings, and a proximal clamping plate, and a distal clamping plate. The proximal clamping plate and the distal clamping plate extend radially outwardly relative to the push rod. The distal clamping plate is connected to the push rod. The proximal clamping plate is arranged between the push rod and the distal clamping plate. A valve holding space is formed between the proximal clamping plate and the distal clamping plate. The push rod is capable of driving the distal clamping plate to be expanded radially. The proximal clamping plate is capable of expanding toward the distal clamping plate by an elastic strain of the proximal clamping plate and is configured to clamp a valve tissue received in the valve holding space.

Abstract: A method and system for performing transseptal extracorporeal membrane oxygenation is disclosed. The method may include puncturing a septum between the right atrium and the left atrium and advancing a catheter system through the puncture and into the aorta. A first portion of the catheter system can remove blood from the patient, in some examples near the inferior vena cava. A second portion can return oxygenated blood to the patient, through the transseptal puncture and into the aorta.

Abstract: Transluminally implantable cardiac valves configured for use in cardiac valve replacement and/or cardiac valve exclusion that are capable of percutaneous delivery on low-profile catheters having 15 French size or less. The implantable cardiac valves are fabricated of from a unitary metal material to form a lattice frame support having a main body portion and valve leaflet portion, and a plurality of elongate biasing arm members. A polymer coating or covering is disposed on the valve leaflet portion and the elongate biasing arm members and subtends space between adjacent pairs of elongate biasing arm members to form valve leaflet portions in which the elongate biasing arms and the polymer coating operate to share a mechanical load thereupon.

Abstract: Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium, through the mitral valve, and into the left ventricle. A ventricular anchor is deployed from the catheter and into a wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter. A leaflet anchor is deployed to secure a mitral valve leaflet to a leaflet suture, with the leaflet suture extending proximally through the catheter. The leaflet suture is secured to the ventricular suture to limit a range of travel of the leaflet in the direction of the left atrium. Also disclosed is an assembled in situ mitral valve leaflet restraint, having a neo papillary muscle and a neo chordae tendinea.

Abstract: A method of manufacturing a heart valve comprises: a step of injection moulding a first part of the heart valve from a first block-copolymer, wherein the injection moulding is performed at a temperature below an order-disorder transition temperature of the block copolymer, such that a phase structure is present in the molten block-copolymer; a step of injection moulding a second part of the heart valve from a second block-copolymer that is different to the first block-copolymer, by over-moulding over the first part to form an over-moulded structure, wherein the injection moulding is performed at a temperature below order-disorder transition temperatures for the first and second block copolymers, such that a phase structure is present in the molten second block-copolymer and remains present in the first block-copolymer; and a step of cooling the over-moulded structure, without heating it above the order-disorder transition temperatures between the step of injection moulding the second part and the step of cool

Abstract: A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.

Abstract: Delivery devices and methods for delivering a stented prosthesis to a target site are disclosed. Disclosed delivery devices include a handle assembly including an actuator, an inner shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a tension management device that is configured to limit the amount of tension that can be applied via the actuator to the at least one tension member. Certain embodiments are configured to apply different tension limits to different tension members that are controlled by a one or more actuators. Other various embodiments include one or more tension adjustors to selectively adjust one or more tension limits.

Abstract: Methods of minimally-invasively treating mitral valve regurgitation. The methods include advancing an intraluminal cardiac device in a collapsed configuration into a coronary sinus, retracting a catheter proximally within the coronary sinus to cause a first expandable anchor of the device to self-expand within the coronary sinus, retracting the catheter proximally within the coronary sinus to expose a connecting member of the device, pulling proximally on the cardiac device to reshape mitral valve tissue to reduce mitral valve regurgitation, retracting the catheter proximally within the coronary sinus to cause a second expandable anchor of the device to self-expand within the coronary sinus, and releasing the intraluminal cardiac device from a delivery device.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Abstract: An device for treating a native valve includes a sealing element and an anchoring element. The sealing element is made from a braided mesh material. The sealing element is dimensioned to be deployed in an annulus of a native valve of a heart at a position between native valve leaflets to contact the native valve leaflets during ventricular systole to create a seal to prevent regurgitation of blood from the left ventricle to the left atrium. The sealing element is configured to both be radially expanded and radially reduced while at the position between the native valve leaflets. The anchoring element is adapted for deployment in the heart, the anchoring element coupled to the sealing element and configured to support the sealing element at the desired position between native valve leaflets.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: A system configured to detach an interventional implant from a cardiac valve includes a guide catheter and a capture mechanism routable through the guide catheter. The capture mechanism comprises a capture hypotube with a container portion/space configured to receive an interventional implant connected to cardiac valve tissue. The capture mechanism also includes a cutting arm axially moveable relative to the capture hypotube. The capture hypotube and the cutting arm each include cutting elements that are brought together upon actuation of the cutting arm to thereby cut the cardiac valve tissue surrounding the interventional implant to free the implant from the cardiac valve.

Abstract: A system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment.

Abstract: A transcatheter device for treating the tricuspid valve regurgitation. The transcatheter device comprises a main shaft, a proximal portion, a distal tail, and a spacer body mounted on the main shaft and located between the proximal portion and the distal tail. This transcatheter device could be used for treating tricuspid valve regurgitation in a patient's heart. All or part of the transcatheter device is supported by the main shaft. The spacer body is mounted on the shaft, which travels through the spacer body. Also disclosed are a coaptation assembly that comprises the transcatheter device, and a method of treating tricuspid valve regurgitation using the transcatheter device.

Abstract: Systems and methods for sequential deployment of a prosthetic valve using a delivery catheter are described. The delivery catheter may include a deployment assembly including an end cone, a distal sleeve, a prosthetic support, an anchor sleeve and an anchor support. The delivery catheter may further include a handle having a manipulator including a guide that is connect to the deployment assembly with a force transmission tube. The guide may have various channels for interfacing with a protrusion of the handle and may be guided by the protrusion to sequentially deploy the prosthetic valve from the deployment assembly. For example, the guide may cause the distal sleeve to release a distal end of the prosthetic valve and subsequently cause an anchor support to release a proximal end of the prosthetic valve.

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

Abstract: A holder for a prosthetic heart valve includes a base having an annular portion defining an aperture, and a spool rotatably mated with the base. The spool has a platform and a head extending in a longitudinal direction from the platform. The holder further includes a button housing having an aperture sized and shaped to receive the head of the spool, and a button inserted in the button housing. The button housing is detachably coupled to the spool in an assembled condition. The button is movable relative to the button housing to move the button housing from a condition locked to the spool to a condition removable from the spool.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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