Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve (i.e., mitral valve and/or tricuspid valve). For tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. There is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: A method of reducing regurgitation between native leaflets of an atrioventricular heart valve includes advancing a delivery catheter through a sheath, wherein the delivery catheter has a valve leaflet coaptation element mounted over a distal end portion. The coaptation element is positioned within the heart valve and is permitted to radially expand from a compressed configuration to an enlarged configuration for filling a gap between the native leaflets of the heart valve. After deployment, the position of the coaptation element is fixed relative to the heart valve, thereby reducing regurgitation between the native leaflets of the heart valve and improving heart function.

Abstract: A system for reducing regurgitation includes a catheter and a coaptation member disposed along a distal end portion of the catheter, wherein the coaption member is sized to be advanced through a patient’s vasculature in a compressed configuration and wherein the coaptation member is expandable for deployment between leaflets of a native tricuspid valve. The coaptation member includes a frame covered with one or more panels of bioprosthetic tissue or flexible polymer to form a three-sided shape having three convex sides separated by rounded corners. An anchor is coupled to a proximal end portion of the catheter and is shaped for attachment to a vessel wall. After deployment, the anchor secures the position of the coaptation member relative to the native tricuspid valve.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve or tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. A proximal anchoring feature fixes the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: A method of reducing regurgitation between native leaflets of an atrioventricular heart valve includes advancing a delivery catheter through a sheath, wherein the delivery catheter has a valve leaflet coaptation element mounted over a distal end portion. The coaptation element is positioned within the heart valve and is permitted to radially expand from a compressed configuration to an enlarged configuration for filling a gap between the native leaflets of the heart valve. After deployment, the position of the coaptation element is fixed relative to the heart valve, thereby reducing regurgitation between the native leaflets of the heart valve and improving heart function.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve or tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. A proximal anchoring feature fixes the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.