Abstract: A method may include accessing a terminal branch of an ophthalmic artery through a face of a subject. Additionally, the method may include positioning a device within the ophthalmic artery of the subject and treating at least one of a blockage, a stenosis, a lesion, plaque or other physiology in at least one of the ophthalmic artery or a junction between an internal carotid artery and the ophthalmic artery.

Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

Abstract: A method may include accessing a terminal branch of an ophthalmic artery through a face of a subject. Additionally, the method may include positioning a device within the ophthalmic artery of the subject and treating at least one of a blockage, a stenosis, a lesion, plaque or other physiology in at least one of the ophthalmic artery or a junction between an internal carotid artery and the ophthalmic artery.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

Abstract: A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.

Abstract: Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

Abstract: Apparatus and methods are described herein for use in the transfemoral delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The delivery sheath is inserted into a femoral vein and moved through the femoral vein and a septum of a heart until a distal end of the delivery sheath is disposed in the left atrium of the heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Abstract: A prosthetic heart valve can include an outer frame coupled to an inner frame such that the outer frame can be moved between a first position and a second position in which the outer frame is inverted relative to the inner frame. The inner frame and the outer frame define between them an annular space, and a pocket closure can bound the annular space to form a pocket in which thrombus can form and be retained. The pocket closure can include a stretchable pocket covering that can move from a first position in which the pocket covering has a first length when the outer frame is in the first position relative to the inner frame and a second position in which the pocket covering has a second length greater than the first length when the outer frame is in the second position relative to the inner frame.

Abstract: Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes an epicardial pad configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The epicardial pad defines a lumen configured to receive therethrough a tether extending from the prosthetic valve. The epicardial pad is movable between a first configuration in which the epicardial pad has a first outer perimeter and is configured to be disposed within a lumen of a delivery sheath and a second configuration in which the epicardial pad has a second outer perimeter greater than the first outer perimeter. The epicardial pad can be disposed against the outside surface of the heart when in the second configuration to secure the prosthetic valve and tether in a desired position within the heart.

Abstract: Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.

Abstract: A method for delivery and deployment of a prosthetic mitral valve into a heart includes inserting an introducer sheath having a prosthetic mitral valve disposed therein in a collapsed configuration into the left atrium of a patient's heart, through a gap between the native mitral valve leaflets, the left ventricle and apex of the heart. An epicardial pad device coupled to the prosthetic valve via a tether is moved distally out of the sheath. The introducer sheath is withdrawn into the left atrium of the heart. An inner delivery sheath is extended distally from within the introducer sheath and disposed within the left atrium. The prosthetic mitral valve is moved distally out of the inner delivery sheath and assumes a biased expanded configuration. The valve is positioned within the mitral annulus of the heart, and secured in place via the tether and epicardial pad device.

Abstract: A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

Abstract: Apparatus and methods are described herein for use in the alignment and deployment of a prosthetic heart valve, such as a mitral valve. In some embodiments, an apparatus includes a tube assembly and a needle assembly configured to be received through a lumen of an outer tube member of the tube assembly. The needle assembly includes an elongate needle having a distal tip configured to be inserted through the epicardial surface of a heart. An imaging probe is coupled to a coupling member and includes an imaging element. The imaging probe is configured to provide image data associated with a location of a commissural-commissural (C-C) plane and a location of the anterior-posterior (A-P) plane of the mitral valve and the annular region of the heart such that a prosthetic mitral valve can be positioned within the heart based at least in part on the C-C plane and the A-P plane.

Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

Abstract: Prosthetic heart valves are described herein that can provide clearance to the left ventricle outflow tract (LVOT), reduce the possibility of undesirable outflow gradients, and/or limit or prevent LVOT obstructions when implanted in the heart. In some embodiments, a prosthetic heart valve can include an outer frame having a cuff portion that is disposed at an angle (e.g., 80 degrees) relative to the vertical axis of a body portion of the outer frame, so that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart. In some embodiments, a prosthetic heart valve can alternatively, or additionally, include subvalvular components having a short profile, such that the prosthetic valve can seat securely in the annulus while not obstructing the ventricular outflow tract of the heart.

Abstract: In some embodiments, an apparatus includes a catheter assembly and a handle assembly that can be removably coupled to the catheter assembly. A valve holding tube defines a lumen configured to receive a prosthetic mitral valve in a compressed configuration and can be removably coupled to a distal end portion of the handle assembly. The valve holding tube can be received within a hub of the catheter assembly when coupled to the handle assembly. The actuator when actuated is configured to cause the tensioning unit to travel along a traveler strap of the catheter assembly moving the handle assembly distally such that a distal end of an elongate shaft of the handle assembly moves the prosthetic mitral valve distally out of the valve holding tube and out a distal end of the sheath such that the prosthetic mitral valve is free to move to a biased expanded configuration.

Abstract: Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

Abstract: Apparatus and methods are described herein for repositioning a tether attached to a prosthetic heart valve. In some embodiments, a method includes inserting a distal end portion of a snare device through an incision at a first location in a ventricular wall of a heart and within the left ventricle of the heart. A tether extending from a prosthetic mitral valve, through the left ventricle and out an incision at a second location on the ventricular wall of the heart is snared with the snare device. The tether is pulled with the snare device such that a proximal end of the tether is moved back through the incision at the second location on the ventricular wall and into the left ventricle. The snare device is pulled proximally such that the tether is pulled proximally through the incision at the first location in the ventricular wall of the heart.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve. In some embodiments, after a prosthetic valve has been at least partially delivered from a delivery sheath into the left atrium of a heart, a valve positioning device can be used to engage with and position the prosthetic valve within the mitral annulus. The valve positioning device can include an alignment member configured to engage with a prosthetic valve such that the alignment member can control the distal, proximal, lateral and/or rotational movement of the prosthetic valve. The prosthetic valve can include a tether that can be inserted or threaded through the alignment member such that the alignment member can be moved along the tether into engagement with the prosthetic valve.