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 proximal anchors can extend a significant distance away from the exterior of the frame, such as a length equal to or greater than about one half the diameter of the frame. As another example, the anchors can have looped ends.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

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.

Abstract: A prosthetic heart valve includes a frame, a valve component, and an actuation mechanism. The frame has a plurality of struts interconnected by a plurality of joints and is movable between expanded and compressed configurations. The valve component is inside the frame and has a plurality of leaflets. The actuation mechanism has a first expansion element coupled to the frame at a first location and a second expansion element coupled to the frame at a second location. The actuation mechanism is configured such that moving the first expansion element and the second expansion element toward each other in a first direction results in the frame moving from the compressed configuration to the expanded configuration, and such that moving the first expansion element and the second expansion element away from each other in a second direction results in the frame moving from the expanded configuration to the compressed configuration.

Abstract: A prosthetic valve includes a tubular frame, a multi-leaflet valve, movable rods, and a flange. The frame includes a lattice, an inflow end portion, and an outflow end portion. The frame is movable between radially collapsed and expanded states. The lattice deflects as the frame moves between the radially collapsed and expanded states. The valve is disposed within and coupled to the frame and is configured to allow one-way blood flow therethrough. The rods are coupled to the lattice of the frame and are configured to facilitate movement of the frame between the radially collapsed and expanded states. The flange is coupled to and extends radially outwardly from the frame and includes deflectable petals. The petals include a first petal having a first length and a second petal having a second length, and the first length is different than the second length.

Abstract: A prosthetic heart valve includes a radially expandable annular frame and a valve body disposed inside the frame. The valve body includes three leaflets configured to regulate the flow of blood through the frame in one direction. The prosthetic heart valve also includes an annular inner skirt secured to an inner surface of the frame. The inner skirt has an inflow edge oriented toward an inflow end of the frame, an outflow edge oriented toward an outflow end of the frame, and first and second lateral edges extending from the inflow edge to the outflow edge, wherein the first lateral edge and the second lateral edge are secured together. The first lateral edge and the second lateral edge are oriented at an oblique angle relative to a plane that is perpendicular to a central longitudinal axis of the frame.

Abstract: A vascular system includes a delivery apparatus and an endovascular device. The delivery apparatus including a catheter and a control lead. The control lead extends through a lumen of the catheter and is configured to be manipulated by a user. The endovascular device is releasably coupled to the delivery apparatus and includes an implant body, a seal extending radially outwardly from the implant body, and one or more tissue engaging elements. The seal is configured to contact native vascular tissue to reduce leakage between the native vascular tissue and the implant body. The tissue engaging elements are pivotable relative to the seal from a compressed state to an expanded state. In the compressed state, the tissue engaging elements are positioned so as to disengage the native vascular tissue. In the expanded state, the tissue engaging elements extend outwardly from the seal and are configured to engage the native vascular tissue.

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: 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 heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

Abstract: A method of implanting a device in a heart includes inserting an implant into a blood vessel with a delivery apparatus. The implant includes a stent member and an adjustment member. The stent member is circumferentially expandable and contractible. The adjustment member is coupled to the stent member. The delivery apparatus includes a rotatable shaft and a locking mechanism coupled to an end portion of the shaft. The shaft of the delivery apparatus is releasably coupled to the adjustment member of the implant by the locking mechanism of the delivery apparatus. The method further includes positioning the implant at an implantation location within a heart by manipulating the delivery apparatus, and rotating the shaft of the delivery apparatus relative to the stent member of the implant to actuate the adjustment member of the implant. Actuating the adjustment member results in circumferential expansion or contraction of the stent member.

Abstract: A prosthetic heart includes a support structure, an actuator member, a plurality of leaflets, and a sealing material. The support structure includes a plurality of struts movably coupled together such that the support structure moves incrementally between a radially compressed state and a radially expanded state. The struts include a plurality of commissure struts. The actuator member is coupled to the struts of the support structure and is configured to incrementally move the support structure between the radially compressed state and the radially expanded state and to automatically lock the support structure in a particular state. The leaflets are coupled to the commissure struts of the support structure and configured to allow unidirectional blood flow through the prosthetic heart valve. The sealing material is coupled to the support structure and includes a plurality of commissure extensions that wrap around and are coupled to the commissure struts of the support structure.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

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: A replacement heart valve can have an expandable frame configured to engage a native valve annulus. A valve body can be mounted onto the expandable frame to provide functionality similar to a natural valve. The valve body has an upstream end and a downstream end, and a diameter at the downstream end is greater than a diameter at the upstream end.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

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 prosthetic heart valve can include a support structure, an actuator member, and a plurality of leaflets. The support structure can have a plurality of struts and a plurality of rivets. The struts can have openings formed therein. The rivets can have first portions and second portions. The first portions can extend through the openings of the struts, and the second portions are larger than the first portion and the openings of the struts. The struts are pivotable about the rivets to radially expand and compress the support structure. The actuator member can be coupled to the struts of the support structure and configured to selectively actuate expansion and compression of the support structure. The leaflets can be coupled to the support structure and configured to allow unidirectional blood flow through the prosthetic heart valve.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.