Abstract: A method for heart valve replacement comprises forming an incision in a wall of a ventricle of a heart and inserting a delivery apparatus and a prosthetic heart valve through the incision and into the ventricle of the heart. The prosthetic valve comprises a self-expanding frame having an annular main body and a valve member disposed within the annular main body. The prosthetic valve further comprises an atrial sealing member formed by an annular metal ring and a fabric, wherein only the fabric of the atrial sealing member is connected to the main body for enhancing the flexibility and conformability of the atrial sealing member. The method further comprises deploying the prosthetic valve from the delivery apparatus such that the atrial sealing member extends radially outwardly from the main body within an atrium of the heart and the main body self-expands to a deployed state within a native heart valve.

Abstract: A prosthetic device includes a main body, a first anchor, and a second anchor. The main body has an atrial end and a ventricular end. The main body tapers from the atrial end to the ventricular end. The first and second anchors are coupled to the main body and are movable toward and away from the main body.

Abstract: An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The device can be deployed from a delivery system including one or more lines which can be decoupled from the device by energizing. The device can include contoured clasps which approximate the shape of the native valve when the clasps are in the closed position. The device can include a coaptation element with body portion including a plurality of struts and openings defining a lattice structure. One or more surfaces of one or more components of the device can be coated to improve the visibility of the device during deployment and implantation.

Abstract: A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.

Abstract: A prosthetic heart valve for implantation at a native heart valve includes a multi-part frame. The multi-part frame includes a cylindrical main body and a ventricular anchor component surrounding the main body. The main body includes a plurality of struts arranged in a lattice pattern. The ventricular anchor component is attached to the main body only at an outflow end of the main body and extends toward an inflow end of the main body. The prosthetic valve further includes a valve structure having three leaflets made from pericardium. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve. The main body and the ventricular anchor component are formed separately and are attached by a locking mechanism for reducing strain between the main body and the ventricular anchor component.

Abstract: A prosthetic heart valve for implantation within a native atrioventricular heart valve. The prosthetic heart valve includes a self-expanding frame having an annular main body and a valve member disposed within the main body. The prosthetic heart valve includes an atrial sealing member formed by a fabric cover and a plurality of arms that are arranged side-by-side in a circumferential direction around the main body. The atrial sealing member extends radially outwardly from the main body and a peripheral portion of the atrial sealing member curves upwardly for conforming to surrounding native anatomy. The prosthetic heart valve further includes one or more ventricular anchors extending from the main body for capturing native leaflet tissue and thereby securing the prosthetic heart valve within the native atrioventricular heart valve.

Abstract: A self-expanding prosthetic heart valve includes an inner frame and an outer sealing frame. A lower region of the outer sealing frame is coupled to a lower region of the inner frame. At least a portion of the outer frame has a D-shape cross-section for conforming to a shape of a native heart valve annulus. Elongate anchors are positioned outwardly from the outer sealing frame for anchoring to native leaflets. Preferably, the native leaflets are secured between the anchors and an outer surface of the outer sealing frame. A valve body is positioned within an interior lumen of the inner frame and provides a one-way valve mechanism for replacing the function of the native leaflets. For additional stability, a further anchoring mechanism may extend from the inner frame for attachment to a heart wall. The prosthetic heart valve is well-suited for replacing the function of a native tricuspid valve.

Abstract: A method of implanting a prosthetic apparatus preferably includes delivering the prosthetic apparatus to a native mitral valve and exposing ventricular anchors and a spacer body of the prosthetic apparatus from a distal end portion of a delivery apparatus. The ventricular anchors are controllably and forcibly expanded outwardly from the spacer body to an expanded configuration. The prosthetic apparatus is positioned relative to the native mitral valve such that native mitral valve leaflets are located between the ventricular anchors and the spacer body. The ventricular anchors are then contracted radially inwardly toward the spacer body to a compressed configuration. In the compressed configuration, the native mitral valve leaflets are secured between the ventricular anchors and the spacer body. After implantation, the spacer body is held between the native mitral valve leaflets, thereby blocking regurgitation and improving the function of the native mitral valve.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor each extend from the spacer body. The spacer body is radially compressible and self-expandable. The spacer body is configured for placement between the anterior and posterior native valve leaflets.

Abstract: A prosthetic heart valve includes an outer frame, a cover, an inner frame, and a valve structure. The outer frame includes a main body and an atrial flange. The main body includes a plurality of struts forming a plurality of circumferential rows of cells, a plurality of rows of barbs extending from junctions of the struts, the atrial flange extending radially outwardly and in an atrial direction from the inflow end of the main body. The atrial flange includes an oval shape corresponding to a shape of the patient's native mitral valve anatomy. The cover is disposed on a radially inner side of the atrial flange and on a radially outer side of the atrial flange. The inner frame is disposed within the outer frame and has a cylindrical shape. The valve structure is coupled to the inner frame and includes a plurality of leaflets.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body. When inside a delivery sheath, the first anchor and the second anchor can extend distally from the spacer body.

Abstract: A prosthetic valve assembly includes a support structure and a valve component. The support structure includes a first frame and a sealing member. The first frame includes a lumen extending between inflow and outflow ends. The sealing member extends inwardly into the lumen of the first frame and includes a first end wall defining a first orifice, a second end wall axially spaced from the first end wall and defining a second orifice, and an inner sleeve extending axially from the first end wall to the second end wall and spaced radially inwardly from the first frame. The valve component includes a second frame and a valve structure supported inside of the second frame for permitting blood flow through the valve component in one direction and blocking blood flow in the opposite direction. The valve component is configured to expand within and engage the inner sleeve of the sealing member.

Abstract: A system for replacing a native valve of the heart includes a delivery apparatus having a sheath and a prosthetic valve. The prosthetic valve includes a frame having an annular main body, a plurality of ventricular anchors attached to the main body, an atrial anchor attached to an atrial end portion of the main body, and a valve structure disposed within the main body of the frame. The prosthetic valve is disposed within a distal end portion of the sheath in a compressed, delivery state. When the prosthetic valve is deployed from the sheath, the main body of the frame radially expands to a radially expanded state, the ventricular anchors expand to a deployed state alongside the main body of the frame for capturing native leaflets of the native valve, and the atrial anchor expands to a deployed state extending radially outwardly from the main body.

Abstract: A prosthetic spacer assembly includes a spacer, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer. The first anchor curves around the spacer when viewed from an upstream end. The second anchor curves around the spacer when viewed from the upstream end.

Abstract: A prosthetic heart valve for implantation at a native heart valve includes a multi-part frame. The multi-part frame includes a cylindrical main body and a ventricular anchor component surrounding the main body. The main body includes a plurality of struts arranged in a lattice pattern. The ventricular anchor component is attached to the main body only at an outflow end of the main body and extends toward an inflow end of the main body. The prosthetic valve further includes a valve structure having three leaflets made from pericardium. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of the native valve. The main body and the ventricular anchor component are formed separately and are attached by a locking mechanism for reducing strain between the main body and the ventricular anchor component.

Abstract: An implantable device or implant includes an anchor portion comprising one or more anchors. The anchors are configured to attach to one or more leaflets of a native heart valve. The anchors are configured to move between an open position and a closed position. The device or implant includes an indication feature that is movable between an allowable tension position and an exceeded tension position. When the anchors are attached to the leaflets of the native heart valve, the indication feature indicates to a user when an amount of force applied to the anchor portion by the leaflets of the native heart valve exceeds a pre-set or predetermined amount of force.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body.

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: A prosthetic apparatus for implantation in a native heart valve includes a main body for placement within the native annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. Ventricular anchors are coupled to a ventricular end portion of the main body. The ventricular anchors are adapted to be straightened for delivery to the native heart valve and are biased to spring back to a pre-formed bent shape for capturing the native heart valve leaflets between the main body and the ventricular anchors. An atrial sealing member may be provided along an atrial portion of the main body for impeding the flow of blood between the main body and the native annulus.

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.