Abstract: A heart valve therapy system includes a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: A delivery system for delivery of a radially expandable device to an implantation site in a patient, the delivery system including an elongated tubular member comprising a distal tip and an outer surface, first and second balloon portions spaced proximally from each other and the distal tip along a length of the tubular member, an annular space between the first and second balloon portions, a plurality of clip deployment tubes extendably moveable relative to the outer surface of the tubular member, and a plurality of clips, wherein each clip is moveable within a length of one of the clip deployment tubes between a retracted position and a deployed position.

Abstract: Devices, systems, and methods for therapeutically treating tissue. The devices and methods are suitable for minimally invasive surgery or open surgical procedures. More particularly, methods and devices described herein permit accessing and/or treating areas of tissue with a therapeutic device.

Abstract: A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Abstract: Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

Abstract: Devices, systems, and methods for therapeutically treating tissue. The devices and methods are suitable for minimally invasive surgery or open surgical procedures. More particularly, methods and devices described herein permit accessing and/or treating areas of tissue with a therapeutic device.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

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: Systems and methods for modifying a heart valve annulus in a minimally invasive surgical procedure. A helical anchor is provided, having a memory set to a coiled shape or state. The helical anchor is further configured to self-revert from a substantially straight state to the coiled state. The helical anchor is loaded within a needle that constrains the helical anchor to the substantially straight state. The needle is delivered to the valve annulus and inserted into tissue of the annulus. The helical anchor is then deployed from the needle (e.g., the needle is retracted from over the helical anchor). Once deployed, the helical anchor self-transitions toward the coiled shape, cinching engaged tissue of the valve annulus.

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: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. The heart valve prosthesis has a valve member and a docking member. When the orifice restriction mechanism is positioned within the docking member within an annulus of the native heart valve, the orifice restriction mechanism temporarily replicates the operation of the native heart valve until the valve member is positioned within the docking member.

Abstract: A delivery system for percutaneously deploying a valve prosthesis. The system includes a catheter assembly including a delivery sheath capsule and a handle having an oscillating device. The capsule is configured to compressively retain the valve prosthesis during implantation. After the valve prosthesis is partially exposed during implantation, the oscillating device can create a vibratory motion to reduce the friction between the valve prosthesis and the delivery sheath capsule in order to recapture the valve prosthesis.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

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 delivery device includes an inner shaft, an outer sheath, a nosecone, and a tether component. The outer sheath is slidably disposed over the inner shaft. The nosecone is removably coupled to the inner shaft. The nosecone includes a delivery configuration for delivery to a treatment site, a radially compressed configuration in which a portion of the nosecone is configured to traverse through a heart wall, and a radially expanded configuration in which an outer surface of the nosecone contacts an outer surface of the heart wall. The tether component includes a first end coupled to the nosecone. The nosecone is configured to plug a piercing in the heart wall when in the radially expanded configuration.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: A delivery device includes an inner shaft, an outer sheath, a nosecone, and a tether component. The outer sheath is slidably disposed over the inner shaft. The nosecone is removably coupled to the inner shaft. The nosecone includes a delivery configuration for delivery to a treatment site, a radially compressed configuration in which a portion of the nosecone is configured to traverse through a heart wall, and a radially expanded configuration in which an outer surface of the nosecone contacts an outer surface of the heart wall. The tether component includes a first end coupled to the nosecone. The nosecone is configured to plug a piercing in the heart wall when in the radially expanded configuration.