Abstract: Valvular regurgitation is addressed by implanting devices at or near a native valve to treat leaflet issues. This can be done by treating the leaflets and/or by treating one or more natural chordae tendineae (chords). Treating the leaflets can include methods and devices that bring different leaflets together, and/or inhibiting or arresting a leaflet from billowing and/or flailing into the atrium. Treating the chords can include methods and devices that shorten chords, that increase tension in the chords, that attach chords to the ventricle wall or to each other, and the like. In each of the disclosed methods and devices, coaptation is increased and/or valvular regurgitation is reduced. The disclosed devices and methods can be performed on a beating heart.

Abstract: A steerable delivery system is provided for delivering a replacement heart valve to a native heart valve location. The steerable delivery system includes an outer sheath assembly having a capsule along a distal end portion for retaining the replacement heart valve in a compressed configuration. The capsule is constructed to provide both compression resistance and flexibility. The capsule may be formed with an outer polymer layer, a metal middle layer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the metal middle layer. A fluoroelastomer layer is provided for bonding the inner liner to the metal middle layer. The metal middle layer is preferably a metal hypotube.

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. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

Abstract: A delivery system includes a suture attachment mechanism for maintaining a connection to a heart valve after initial deployment, thereby allowing recapture of the heart valve if desired. A plurality of suture portions is provided along a distal end portion of the delivery system, each suture portion having a first end fixed to the delivery system and a second end releasably coupled to a retention member on the delivery system. A knob on a handle of the delivery system is actuated for causing the second end of each suture portion to be released from its respective retention member, thereby allowing the suture portions to be decoupled from the heart valve. The suture portions are located only along a distal end portion of the delivery system for improving reliability and consistency.

Abstract: A prosthetic heart valve for deployment in a native heart valve. The prosthetic heart valve includes an inner frame and a plurality of anchors extending from a distal portion of the inner frame. An outer sealing frame is positioned radially outward of the inner frame. The distal end portion of the outer frame is attached to a distal portion of the inner frame by a flexible cloth material such that the outer frame can move axially or tilt with respect to the inner frame. The anchors are shaped to capture native leaflets between the anchors and the outer frame to secure the prosthetic valve in the native heart valve. Prosthetic valve leaflets are provided in a lumen of the inner frame for allowing one way flow through the prosthetic valve, thereby replacing the function of the native heart valve.

Abstract: Apparatuses, systems, and methods for prosthetic valves. Embodiments of prosthetic valves may include sealing bodies configured for an anchor to at least partially pass through. The pass through may allow for the sealing body to seal to a portion of a patient's heart in the event of a miscapture of a leaflet by the anchor. Embodiments may include modular valve systems and prosthetic valves including anchors for coupling to chordae, trabeculae, or papillary structures of a patient's heart. Embodiments may include prosthetic valves including anchors for engaging calcification of a patient's native valve.

Abstract: Devices, systems and methods are described herein to provide improved treatment of a tricuspid valve. Such treatment may include tricuspid valve replacement, which may include providing a prosthetic tricuspid valve within the tricuspid valve annulus. Delivery systems for delivering the prosthetic tricuspid valve to the tricuspid valve annulus are disclosed herein. Treatment may also include repair of the tricuspid valve.

Abstract: Embodiments of the present disclosure are directed to delivery systems, devices and/or methods of use to deliver and/or controllably deploy an implant in the form of a prosthesis, such as but not limited to a replacement heart valve, to a desired location within the body. In some embodiments, a replacement heart valve and methods for delivering a replacement heart valve to a native heart valve, such as a mitral valve, are provided. Features of delivery systems are disclosed, as well as echogenic markers for delivery systems.

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. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

Abstract: Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially-inwardly of the inner surface of the first leaflet.

Abstract: Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially-inwardly of the inner surface of the first leaflet.

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. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

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. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

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. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

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. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

Abstract: Embodiments are provided of an assembly having a prosthetic valve, the prosthetic valve having a radially expandable and compressible annular frame, and a crimping accessory device, and methods for using the assembly in compressing the prosthetic valve. The frame includes an outer surface and an inner surface. A leaflet assembly is supported inside the annular frame. The leaflet assembly includes a plurality of leaflets, each having an inner surface and an outer surface. The crimping accessory device has a plurality of axially-extending fingers. At least a first finger of the plurality of fingers is disposed between the outer surface of a first leaflet of the plurality of leaflets, and at least a second finger of the plurality of fingers is disposed radially-inwardly of the inner surface of the first leaflet.