Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

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

Abstract: 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 prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the frame can have a larger cross-sectional dimension in a middle portion of the frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the frame, wherein the middle portion is between the proximal and distal portions. As another example, the anchors can have looped ends, the entire anchor may loop out from the frame.

Abstract: A method for implanting a replacement heart valve within a diseased valve includes accessing a patient's heart by piercing a myocardium, advancing a guidewire into the patient's heart, and installing an access device in a wall of the heart. The access device preferably has at least one valve mechanism. A valve delivery device is advanced over the guidewire and through the access device. The valve delivery device has a replacement heart valve disposed along a distal end portion thereof. The replacement heart valve preferably includes an outer support structure and a leaflet valve disposed within the outer support structure. The replacement heart valve is radially expanded within the diseased valve. During implantation, the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size having a diameter smaller than the diameter of the diseased valve.

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

Abstract: A frame for a prosthetic valve includes pivoting struts and outer bow struts. A first end of each pivoting strut is pivotably coupled to a first pivoting strut, a second end of each pivoting strut is pivotably coupled to a second pivoting strut, and an intermediate portion of each pivoting strut, which is disposed between the first end and the second end, is pivotably coupled to a third pivoting strut. The outer bow struts are disposed outwardly from the pivoting struts. An inflow end of each outer bow strut is connected to the first end of a respective pivoting strut, and an outflow end of each outer bow strut is connected to the second end of a respective pivoting strut. The outer bow struts deflect outwardly relative to the intermediate portions of the pivoting struts when the frame is moved from a radially compressed configuration to a radially expanded configuration.

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 two-part heart valve prosthesis comprising a self-expanding valve cage stent and a bi-leaflet tissue valve secured thereto. A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Abstract: A prosthetic heart valve can include an inner support structure, a valve member, and an outer support structure. The inner support structure can have a plurality of first struts coupled together by first pivot joints and forming a first lumen. The valve member can be disposed within the first lumen and coupled to the inner support structure. The valve member can include a plurality of leaflets configured for permitting blood flow through the valve member in one direction. The outer support structure can have a plurality of second struts coupled together by second pivot joints and can form an annulus portion, an outflow portion, and a second lumen. The outflow portion can extend radially outwardly relative to the annulus portion, and the inner support structure and the valve member can be disposed within the second lumen and be coupled to the outer support structure.

Abstract: A method for implanting a replacement heart valve within a diseased valve includes accessing a patient's heart by piercing a myocardium, advancing a guidewire into the patient's heart, and installing an access device in a wall of the heart. The access device preferably has at least one valve mechanism. A valve delivery device is advanced over the guidewire and through the access device. The valve delivery device has a replacement heart valve disposed along a distal end portion thereof. The replacement heart valve preferably includes an outer support structure and a leaflet valve disposed within the outer support structure. The replacement heart valve is radially expanded within the diseased valve. During implantation, the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size having a diameter smaller than the diameter of the diseased valve.

Abstract: A prosthesis for placement within a native heart valve preferably includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors is disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a native annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: A method for delivering a heart valve prosthesis to a native valve annulus comprises expanding an expandable frame at the native valve annulus and positioning a replacement heart valve within the expandable frame. The expandable frame preferably includes a first anchoring portion that is positioned on a first side of the native valve annulus and a second anchoring portion that is positioned on a second side of the native valve annulus. The first anchoring portion engages tissue on the first side of the native valve annulus and the second anchoring portion engages tissue on the second side of the native valve annulus for securing the expandable frame to the native valve annulus. The replacement heart valve comprises a plurality of leaflets for replacing the function of the native valve.

Abstract: A method of implanting a replacement mitral valve can include expanding a replacement mitral valve to a first expanded configuration. The replacement mitral valve can include a force-expanding mitral valve lattice and a self-expanding valve trampoline lattice. The mitral valve lattice has an inflow end portion and an outflow end portion, and the valve trampoline lattice is attached to the outflow end portion of the mitral valve lattice. The method can also include rotating a plurality of jack screws connected to the mitral valve lattice. The jack screws can be configured to expand the mitral valve lattice from the first expanded configuration to a second expanded configuration.

Abstract: A method for implanting a replacement heart valve within a diseased valve includes accessing a patient's heart by piercing a myocardium, advancing a guidewire into the patient's heart, and installing an access device in a wall of the heart. The access device preferably has at least one valve mechanism. A valve delivery device is advanced over the guidewire and through the access device. The valve delivery device has a replacement heart valve disposed along a distal end portion thereof. The replacement heart valve preferably includes an outer support structure and a leaflet valve disposed within the outer support structure. The replacement heart valve is radially expanded within the diseased valve. During implantation, the outer support structure conforms to a diameter of the diseased valve and the leaflet valve expands to a fixed size having a diameter smaller than the diameter of the diseased valve.

Abstract: Methods for delivering a replacement heart valve include advancing a delivery system through a femoral vein and into the atrium of a heart, wherein the delivery system includes an outer sheath assembly, a mid shaft assembly and an inner assembly. The outer sheath assembly and the mid shaft assembly are adapted to retain the replacement heart valve in a radially compacted state over the inner assembly. The outer sheath assembly is retracted to allow a plurality of distal anchors to self-expand while a portion of the replacement heart valve remains retained in a compacted state by the mid shaft assembly. The distal anchors are positioned to engage one or more native leaflets and the retained portion of the replacement heart valve is then released and allowed to fully expand for implanting the replacement heart valve within the native valve.

Abstract: A prosthetic heart valve includes a frame, a valve, and an expansion element. The frame is movable between contracted and expanded configurations and includes first struts and second struts non-hingedly coupled together. The second struts are configured to pivot relative to the first struts as the frame moves between the contracted and expanded configurations. The valve is coupled to the frame and includes leaflets. The expansion element extends through a lumen of the first struts. The expansion element is slidable relative to the lumen of the first struts and is configured to move the frame incrementally from the contracted configuration and the expanded configuration and from the expanded configuration to the contracted configuration.

Abstract: A prosthesis for placement within a native mitral valve includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors are disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a mitral annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.

Abstract: A prosthetic heart valve includes a frame, a valve component, and a skirt. The frame has first and second end portions, a central longitudinal axis extending between the first and second end portions, and a plurality of struts interconnected by a plurality of joints. The joints comprise a rotational axis perpendicular to the longitudinal axis. The frame is movable between an expanded configuration and a compressed configuration. The struts comprise diagonal struts relative to the longitudinal axis when the frame is in the expanded configuration. The valve component has a plurality of leaflets. Adjacent leaflets are attached together and to the frame at commissures of the frame. The leaflets extend from the commissures in a triangular configuration and are attached to adjacent diagonal struts of the frame. The skirt is configured for reducing paravalvular leakage and attached to the diagonal struts of the frame to which the leaflets are attached.

Abstract: A method of implanting a prosthetic implant includes advancing a prosthetic implant into a patient's vasculature with a delivery apparatus, the delivery apparatus comprising a catheter and a control lead, the catheter including a lumen extending therethrough, the control lead extending through the lumen of the catheter, the prosthetic implant comprising an implant body, a seal extending radially outwardly from the implant body, and a locking bar coupled to the implant body and releasably coupled to the control lead, the locking bar radially offset relative to the central longitudinal axis of the implant body. The method further includes rotating the control lead of the delivery apparatus in a first direction relative to the catheter such that the locking bar rotates in the first direction relative to the implant body and the implant body expands radially from a first radially compressed state to a first radially expanded state.