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: Disclosed are embodiments of delivery systems for delivery of replacement heart valves. This can include mitral, aortic, tricuspid, and pulmonary valves. The delivery systems can include one or more different components and configurations that advantageously improve placement of the replacement heart valves during the operation of the delivery system.

Abstract: Apparatuses and methods for loading and deploying implants from delivery apparatuses. The apparatuses in certain embodiments may comprise crimping devices for compressing an implant for insertion into a portion of a delivery apparatus. The apparatuses in certain embodiments may comprise features of delivery apparatuses allowing for improved loading and deployment of an implant from the delivery apparatuses.

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: 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: 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: 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. 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: Disclosed herein are embodiments of an expandable replacement heart valve prosthesis. The expandable replacement heart valve prosthesis can include a number of different features, such as an hourglass (or generally hourglass) shape in the fully expanded position, anchor stiffening features, and improved retraction/retention configurations. For example, certain struts on the prosthesis can have different thicknesses/widths than other struts to improve compressibility.

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: A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.

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 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: 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 mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.