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 mitral valve prosthesis includes an expandable frame having a proximal end, a distal end, and a middle portion. A plurality of tips extends from the proximal end of the frame for attachment to a delivery catheter. A plurality of anchors is disposed along the distal end of the frame and extend toward the proximal end for engaging tissue. An outer circumferential portion extends around the middle portion of the frame and is positioned radially outwardly of the frame. The outer circumferential portion preferably increases in diameter along a distal direction. A distal end of the outer circumferential portion is located distal of free ends of the anchors when the expandable frame is deployed. A valve body is positioned within an interior of the expandable frame and includes leaflets adapted to allow flow in a first direction and prevent flow in a second direction.

Abstract: A replacement heart valve includes a self-expanding frame having an upstream end and a downstream end. A plurality of anchors extends from the downstream end of the frame. A valve skirt is attached to the frame and a valve body is attached to the valve skirt, wherein the valve body includes leaflets for providing one-way flow through the replacement valve. The frame preferably includes a plurality of connector eyelets sized to receive at least one tether. The replacement heart valve is radially collapsible for delivery within a delivery device and radially expandable for engaging a native heart valve annulus upon release from the delivery device. The tether may be used to control expansion and/or adjust the diameter of the replacement heart valve during deployment.

Abstract: Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.

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 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: Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.

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: Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.

Abstract: A prosthetic heart valve includes an expandable stent frame including struts arranged in a zig-zag pattern and leaflets supported within the frame. The leaflets allow blood to flow in only one direction through the frame for replacing the function of a native heart valve, wherein each leaflet has a downstream edge and a cusp edge with opposing side edges. An inner skirt is positioned inside the frame and includes leaflet supports extending from an upstream ring portion of the skirt. The leaflet supports taper in width in a direction extending from the upstream end portion of the frame toward the downstream end portion of the frame. Each leaflet support is disposed between and coupled to adjacent side edges of two adjacent leaflets.

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: Systems and methods for treating heart failure by redirecting blood flow in the azygos vein are disclosed, as well as systems, devices, and methods for controllably and selectively occluding, restricting, and/or diverting flow within a patient’s vasculature. Systems, devices and methods that redirect blood flow in the azygos vein. Devices may include an implant configured to redirect blood from a pulmonary artery to an azygos vein, and an implant configured to be positioned in an azygos vein of a patient to at least partially occlude blood flow from the azygos vein into a superior vena cava.

Abstract: Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.

Abstract: Disclosed herein are delivery systems and methods for delivering a prosthetic heart valve to a native heart valve of a heart. An exemplary delivery system may include a shaft portion having at least one shaft, at least one steering wire, and at least one pull wire. The system may further include a handle portion coupled to a proximal end of the shaft portion and a capsule portion coupled to a distal end of the shaft portion. The capsule portion may be configured to house the prosthetic heart valve. At least one portion of the delivery system may be configured to be engaged with the prosthetic heart valve when the prosthetic heart valve is implanted in the native heart valve of the heart.

Abstract: A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

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 replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

Abstract: Methods are described herein for delivering a replacement valve to a native valve location. In one method, ventricular anchors of the replacement valve are released and allowed to reverse orientation while positioned in the atrium of a human heart. After reversing orientation, the ventricular anchors extend in a generally proximal direction. The ventricular anchors can then be advanced through the annulus into the ventricle and then moved back toward the atrium to capture native valve leaflets between the main body and the ventricular anchors of the replacement valve. In one modification, the ventricular anchors are allowed to reverse orientation at a level adjacent the annulus. The implantation methods described herein are preferably performed via a transseptal delivery approach or a transapical delivery approach.