Abstract: A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.

Abstract: This document provides devices and methods for the treatment of heart conditions. For example, this document provides prosthetic heart valves and transcatheter heart valve replacement methods. The prosthetic heart valves can be configured into a low-profile configuration for containment within a small diameter delivery sheath. The prosthetic heart valves include can include a valve member attached to a stent frame. In some embodiments, the valve member is a molded biomaterial with a novel shape and resulting performance characteristics. Localized protective covering members can be attached to the stent frame to prevent the valve member from contacting the stent frame as the valve member cycles between its open and closed configurations.

Abstract: A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.

Abstract: A replacement heart valve prosthesis for transcatheter repair of a native valve, the replacement heart valve comprises a valve construct mounted to the exterior surface of an expandable frame. The frame comprises an expandable region near the distal end of the frame, and a cusp region near the proximal region comprising a plurality of valve attachment features. The valve construct may be attached to the valve construct at least at the valve attachment features. The replacement heart valve prosthesis of present disclosure may be a more durable and long-lasting valve that has added benefits by placing valve tissue between the expandable frame and native cardiac tissue.

Abstract: A replacement heart valve assembly where the valve is loaded into the catheter distally, and separately from the stent. The valve has a locking member and the stent has a locking channel. Once in the expanded position, the valve is pulled towards the stent until the locking member is engaged with the locking channel.

Abstract: A packaging system for storing a deployable medical device within a sterilized environment includes a sealed container; a tray disposed within the sealed container; a catheter assembly comprising at least one sheath; a deployable medical device engaged with the catheter assembly; and a sterilizing fluid. The tray comprises a first chamber; a second chamber in fluid communication therewith; and at least a third chamber between the first and second chambers, and in fluid communication with at least the first chamber. The deployable medical device is disposed within the tray in a storage configuration, in which the deployable medical device is disposed within the first chamber in a partially deployed state distally from a distal end of the catheter and the catheter assembly spans between the first chamber and the second chamber. The sterilizing fluid contacts at least a part of the deployable medical device in the storage configuration.

Abstract: A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

Abstract: A heart valve assembly for endovascular heart repair, where the valve is in an inverted position relative to the stent to reduce the diameter of the device for delivery and deployment. The heart valve assembly has an expandable stent and a valve. The valve having a proximal end and a distal end, the proximal end of the valve connected to the distal end of the expandable stent, wherein the valve extends distally from the distal end of the expandable stent.

Abstract: A replacement heart valve prosthesis for transcatheter repair of a native valve, the replacement heart valve comprises a valve construct mounted to the exterior surface of an expandable frame. The frame comprises an expandable region near the distal end of the frame, and a cusp region near the proximal region comprising a plurality of valve attachment features. The valve construct may be attached to the valve construct at least at the valve attachment features. The replacement heart valve prosthesis of present disclosure may be a more durable and long-lasting valve that has added benefits by placing valve tissue between the expandable frame and native cardiac tissue.

Abstract: A replacement heart valve prosthesis for transcatheter repair of a native valve comprises a frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an exterior surface and an interior surface defining a lumen, the frame expandable from an unexpanded state to an expanded state. The frame further comprises an expandable region near the distal end of the frame and a cusp region near the proximal end of the frame. The cusp region has a plurality of valve attachment features. A valve construct is mounted to the exterior surface of the frame and attached to the frame at least at the valve attachment features.

Abstract: A replacement heart valve assembly where the valve is loaded into the catheter distally, and separately from the stent. The valve has a locking member and the stent has a locking channel. Once in the expanded position, the valve is pulled towards the stent until the locking member is engaged with the locking channel.

Abstract: A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.

Abstract: A replacement heart valve prosthesis for transcatheter repair of a native valve, the replacement heart valve comprises a valve construct mounted to the exterior surface of an expandable frame. The frame comprises an expandable region near the distal end of the frame, and a cusp region near the proximal region comprising a plurality of valve attachment features. The valve construct may be attached to the valve construct at least at the valve attachment features. The replacement heart valve prosthesis of present disclosure may be a more durable and long-lasting valve that has added benefits by placing valve tissue between the expandable frame and native cardiac tissue.

Abstract: A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.

Abstract: A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

Abstract: This document provides devices and methods for the treatment of heart conditions. For example, this document provides prosthetic heart valves and transcatheter heart valve replacement methods. The prosthetic heart valves can be configured into a low-profile configuration for containment within a small diameter delivery sheath. The prosthetic heart valves include can include a valve member attached to a stent frame. In some embodiments, the valve member is a molded biomaterial with a novel shape and resulting performance characteristics. Localized protective covering members can be attached to the stent frame to prevent the valve member from contacting the stent frame as the valve member cycles between its open and closed configurations.

Abstract: A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.

Abstract: A replacement heart valve assembly where the valve is loaded into the catheter distally, and separately from the stent. The valve has a locking member and the stent has a locking channel. Once in the expanded position, the valve is pulled towards the stent until the locking member is engaged with the locking channel.

Abstract: A valve for endovascular heart valve repair that provides improved sealing of the valve against the native wall. The valve assembly has a sealing region at a distal end of the valve. The sealing region having a delivery position and a sealing position, wherein in the delivery position, the sealing region has a first length, and in the sealing position, the sealing region has a second length less than the first length and a thickness in the sealing position is greater in the sealing position than in the delivery position.

Abstract: A packaging system for storing a deployable medical device within a sterilized environment includes a sealed container; a tray disposed within the sealed container; a catheter assembly comprising at least one sheath; a deployable medical device engaged with the catheter assembly; and a sterilizing fluid. The tray comprises a first chamber; a second chamber in fluid communication therewith; and at least a third chamber between the first and second chambers, and in fluid communication with at least the first chamber. The deployable medical device is disposed within the tray in a storage configuration, in which the deployable medical device is disposed within the first chamber in a partially deployed state distally from a distal end of the catheter and the catheter assembly spans between the first chamber and the second chamber. The sterilizing fluid contacts at least a part of the deployable medical device in the storage configuration.