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 system for implanting a replacement heart valve at a native valve location between an atrium and a ventricle of a patient includes a replacement valve having an expandable frame and a plurality of prosthetic valve leaflets positioned within the expandable frame. A delivery device is provided for delivering the replacement heart valve to the native valve location. The delivery device includes an elongate inner tube having an inner retention ring for coupling to and end of the replacement heart valve and an outer support tube slidable over the inner retention ring for securing the replacement heart valve to the inner retention ring. The inner retention ring preferably includes slots for receiving struts of the expandable frame. The expandable frame preferably includes a plurality of anchors extending from the downstream portion in an upstream direction for extending between chordae and for placement outside of the native leaflets.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: A system for treating aortic dissection including an aortic dissection implant comprising an expandable anchoring structure and an elongate tubular structure. The expandable anchoring structure can be configured to apply radial force to the sinuses of the aortic root and/or the sinotubular junction when expanded. The elongate tubular structure can comprise an expandable support frame and one or more layers. The expandable support frame can be configured to extend from the descending aorta to the ascending aorta and curve along with a curvature of the aortic arch when expanded within the aorta. The one or more layers can comprise a first porous layer comprising an atraumatic outer surface positioned over the expandable support frame and a second non-porous layer positioned over a portion of the first porous layer. The second non-porous layer may be configured to be positioned on opposite sides of the aortic dissection and to be inflatable via blood flow to seal against the dissection.

Abstract: A system for treating atrial dysfunction, including heart failure and/or atrial fibrillation, that includes one or more pressurizing elements and control circuitry. The one or more pressurizing elements can comprise one or more balloons and can be configured to be positioned in the left atrium, and optionally the pulmonary artery, of a patient's heart. The one or more pressurizing elements can be coupled to one or more positioning structures that can be configured to position the one or more pressurizing elements in the left atrium, and optionally the pulmonary artery. The control circuitry can be configured to operate the one or more pressurizing elements to decrease or increase pressure and/or volume in the left atrium, and optionally the pulmonary artery, in accordance with different phases of the cardiac cycle.

Abstract: A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

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

Abstract: A system for treating aortic dissection including an aortic dissection implant comprising an expandable anchoring structure and an elongate tubular structure. The expandable anchoring structure can be configured to apply radial force to the sinuses of the aortic root and/or the sinotubular junction when expanded. The elongate tubular structure can comprise an expandable support frame and one or more layers. The expandable support frame can be configured to extend from the descending aorta to the ascending aorta and curve along with a curvature of the aortic arch when expanded within the aorta. The one or more layers can comprise a first porous layer comprising an atraumatic outer surface positioned over the expandable support frame and a second non-porous layer positioned over a portion of the first porous layer. The second non-porous layer may be configured to be positioned on opposite sides of the aortic dissection and to be inflatable via blood flow to seal against the dissection.

Abstract: A method of treating a diseased native valve includes advancing a replacement heart valve to native valve annulus. The heart valve includes an expandable frame and a valve body. The frame is formed with a plurality of cells and the valve body is formed with a plurality of leaflets configured to allow blood flow in a first direction. The frame is expanded from a radially compacted configuration to an expanded configuration at the native valve annulus. The replacement heart valve also includes one or more openings covered by one or more flaps and blood is allowed to flow through the openings in the first direction.

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 system for treating atrial dysfunction, including heart failure and/or atrial fibrillation, that includes one or more pressurizing elements and control circuitry. The one or more pressurizing elements can comprise one or more balloons and can be configured to be positioned in the left atrium, and optionally the pulmonary artery, of a patient's heart. The one or more pressurizing elements can be coupled to one or more positioning structures that can be configured to position the one or more pressurizing elements in the left atrium, and optionally the pulmonary artery. The control circuitry can be configured to operate the one or more pressurizing elements to decrease or increase pressure and/or volume in the left atrium, and optionally the pulmonary artery, in accordance with different phases of the cardiac cycle.

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 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 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 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 method of deploying a prosthesis within a native mitral valve is disclosed. The expandable frame preferably includes about twelve proximal anchors, wherein the proximal anchors have free ends positioned radially outwardly from the frame in an expanded configuration. The expandable frame preferably includes about twelve distal anchors, wherein the distal anchors also have a free ends positioned radially outwardly from the frame and extend toward a proximal end when the frame is in the expanded configuration. A valve body is supported within the frame for preventing blood flow in one direction. The expandable frame is radially expanded during deployment, which causes the free ends of the proximal and distal anchors to move closer together. In the expanded configuration, the proximal anchors are positioned on an inflow side of the native mitral valve and the distal anchors are positioned on an outflow side of the native mitral valve.

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 replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.