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 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: 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 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: 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: 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: 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 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 or device for isolating pulmonary pressure from left atrial pressure and/or improving cardiac output. The device may be an implantable cardiac device comprising an intravascular shield. The system may comprise an intravascular shield and a trans-septal delivery sheath. The intravascular shield can be sized and configured to be positioned in a pulmonary vein or a left atrium to restrict fluid flow from the left atrium through one or more pulmonary veins to the lungs while allowing fluid flow from the lungs through the one or more pulmonary veins to the left atrium. The trans-septal delivery sheath can be configured to contain the intravascular shield in a collapsed configuration and deliver the intravascular shield to the left atrium.

Abstract: A replacement heart valve includes an expandable frame for engaging a native valve annulus and a valve body positioned within the expandable frame. The valve body has an upstream end and a downstream end, wherein a diameter at the downstream end is greater than a diameter at the upstream end. The replacement heart valve also includes an elongate upstream portion having an inflow diameter, a transition portion that flares outwardly, and a downstream portion configured to engage a native valve annulus.

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.