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: 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.

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: 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 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: 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: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

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: 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: Described herein are prosthetic heart valves and methods for improving the functionality of native heart valves. An exemplary prosthetic heart valve may include one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal. The prosthetic heart valve may include a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway. The at least one support structure may be configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Abstract: A method for replacing a native heart valve includes advancing a delivery catheter having a valve prosthesis disposed along a distal end portion thereof, wherein the valve includes an inner frame having an hourglass shape and an outer sealing frame connected to and surrounding the inner frame. A valve body is mounted within the inner frame and includes a plurality of leaflets. The leaflets have longitudinal curvatures when in an open position, wherein the curvatures are shaped for conforming to the curved interior surface of the inner frame. This combination of features reduces the possibility of blood stagnating between the leaflets and inner frame, which reduces the possibility of thrombus formation.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement valve to a native valve location in a heart. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location. In one preferred delivery system, a proximal handle can be manipulated to apply tension to a pair of diametrically opposed axial runner wires extending through lumens in a wall of a flexible tubular shaft. By applying tension to a pair of axial runner wires, the tubular shaft can be stiffened along a plane extending substantially through the pair of axial runner wires, while the shaft is permitted to freely bend in a perpendicular plane. This feature advantageously provides the ability to adjust the steerability and flexibility of a tubular shaft to meet the requirements of a particular procedure.

Abstract: Guide wire apparatuses and methods. Guide wires may be utilized for guiding a delivery apparatus, for example a transcatheter mitral valve delivery apparatus to replace a native mitral valve. A guide wire may include a core body having a length, and an outer layer having a length and extending around the core body and along the length of the core body. A guide wire may include an intermediate layer positioned between the core body and the outer layer and configured to be retracted relative to the core body and the outer layer along the length of the core body and the length of the outer layer.

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 prosthesis for placement within a native heart valve preferably includes an expandable frame having locking tabs disposed along a proximal end. A plurality of distal anchors is disposed along a distal end of the frame. Each distal anchor is provided with a cushion cover. An outer fabric member surrounds the frame and may extend outwardly from the frame in an expanded condition for providing an improved seal in the region of a native annulus. A valve body is positioned within an interior of the expandable from for allowing blood flow in only one direction. In preferred embodiments, the cushions are positioned over enlarged head portions of the distal anchors for further reducing trauma on surrounding tissue.