Abstract: An assembly for delivering a prosthetic heart valve to a native heart valve is disclosed. The assembly includes a self-expanding prosthetic heart valve formed with an expandable metallic stent and a flexible valvular structure. The assembly also includes a delivery apparatus having a delivery sleeve. The delivery sleeve includes a selectively steerable section and a distal portion for retaining the prosthetic heart valve in a compressed state. A handle is coupled to a proximal end of the delivery sleeve and a pull wire extends from the handle to the steerable section of the delivery sleeve. The handle preferably includes a rotatable portion for actuating the pull wire and thereby selectively controlling a curvature of the steerable section during advancement through the patient's vasculature. In preferred embodiments, the steerable section includes a flexible metallic tubular portion formed with a plurality of circumferentially extending openings.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: In a representative embodiment, an implantable prosthetic heart valve device comprises an elongated body having first and second end portions, the body being configured to be implanted around a native leaflet of a heart valve such that the first end portion is on an atrial side of the leaflet and the second end portion is on a ventricular side of the leaflet and such that the body can coapt with and move away from an opposing native leaflet during operation of the heart valve. The device can further comprises a fastener configured to be mounted on a suture that extends from one of the first or second end portions, through the native leaflet and through the other of the first or second end portions such that the body is secured to the native leaflet.

Abstract: An assembly for treating a native valve in a human heart includes a prosthetic heart valve having an expandable frame and a valvular structure. The assembly also includes a tubular sleeve and a valve catheter disposed within the sleeve. A plurality of metal extension arms are coupled to the valve catheter for holding the prosthetic heart valve. The extension arms are configured to radially expand with the prosthetic heart valve during expansion of the prosthetic heart valve at a treatment site. A plurality of metal rods extend distally from the valve catheter. The rods are axially movable relative to the extension arms. A plurality of release members are provided for releasing the prosthetic heart valve from the extension arms upon movement of the metal rods.

Abstract: In a representative embodiment, an implantable prosthetic heart valve device comprises an elongated body having first and second end portions, the body being configured to be implanted around a native leaflet of a heart valve such that the first end portion is on an atrial side of the leaflet and the second end portion is on a ventricular side of the leaflet and such that the body can coapt with and move away from an opposing native leaflet during operation of the heart valve. The device can further comprises a fastener configured to be mounted on a suture that extends from one of the first or second end portions, through the native leaflet and through the other of the first or second end portions such that the body is secured to the native leaflet.

Abstract: A method of delivering a prosthetic heart valve to a native aortic valve is disclosed. The prosthetic heart valve comprises a radially compressible and expandable metallic stent and a flexible valvular structure. A delivery system comprises a selectively steerable section and a pusher member extending through a central lumen of the steerable section. The prosthetic heart valve is compressed and inserted into a distal end portion of the delivery system. The delivery system and prosthetic heart valve are advanced through a femoral artery and around an aortic arch. A pull wire is actuated for selectively controlling a curvature of the steerable section during advancement around the aortic arch. The pusher member is advanced for ejecting the prosthetic heart valve from the delivery system into the native aortic valve, wherein the prosthetic valve self-expands after ejection.

Abstract: A wound closure device comprises a first frame and a flexible tubular section connected to the first frame, the first frame implantable through a wound in a patient's skin into a lumen of a blood vessel with a portion of the tubular section extending out through the skin. The tubular section has a first portion and a second portion, a wall of the tubular section defining a coaxial inner bore. Twisting the first portion relative to the second portion of the tubular section closes the bore is closed in an area of the tubular section between the first and second portions, thereby closing the wound. Also disclosed is an embodiment for closing an opening in a heart, as well as a delivery device, systems, and methods.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: An assembly for treating a native heart valve can include a prosthetic valve and a delivery apparatus. The prosthetic valve can include an expandable frame, a valve structure, a first end with apertures formed therein, and a second end. The delivery apparatus can include a valve catheter, flexible extension arms, slidable wires, and release members. First ends of the arms can be coupled to a cylindrical coupling element, second ends of the arms can be releasably coupled to the prosthetic valve, and the coupling element can be connected to the distal end of the valve catheter. The slidable wires can extend distally from the distal end of the valve catheter. The release members can be coupled to the distal end of the valve catheter and can extend through a respective aperture of the prosthetic valve, thereby forming a releasable connection between the prosthetic valve and the slidable wires.

Abstract: The present disclosure provides embodiments of a method for improving coaptation of the anterior and posterior mitral valve leaflets by applying a remodeling force to the posterior leaflet. In particular embodiments, a tension member is secured at a location on or proximate to the posterior leaflet. Tension can be applied to the tension member in a direction superiorly and anteriorly toward the interatrial septum. The tension member can be secured at a location proximate the septum to maintain the tension. The tension provides the remodeling force, pulling the posterior leaflet superiorly and anteriorly to improve coaptation with the anterior leaflet.

Abstract: A wound closure device comprises a first frame and a flexible tubular section connected to the first frame, the first frame implantable through a wound in a patient's skin into a lumen of a blood vessel with a portion of the tubular section extending out through the skin. The tubular section has a first portion and a second portion, a wall of the tubular section defining a coaxial inner bore. Twisting the first portion relative to the second portion of the tubular section closes the bore is closed in an area of the tubular section between the first and second portions, thereby closing the wound. Also disclosed is an embodiment for closing an opening in a heart, as well as a delivery device, systems, and methods.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is located distally to the valve. A removable tab is disposed between the distal end of the frame and the nose cone. The tab assists in maintaining the position of the nose cone relative to the distal end of the frame.

Abstract: An assembly for treating a native heart valve can include a prosthetic valve and a delivery apparatus. The prosthetic valve can include an expandable frame, a valve structure, a first end with apertures formed therein, and a second end. The delivery apparatus can include a valve catheter, flexible extension arms, slidable wires, and release members. First ends of the arms can be coupled to a cylindrical coupling element, second ends of the arms can be releasably coupled to the prosthetic valve, and the coupling element can be connected to the distal end of the valve catheter. The slidable wires can extend distally from the distal end of the valve catheter. The release members can be coupled to the distal end of the valve catheter and can extend through a respective aperture of the prosthetic valve, thereby forming a releasable connection between the prosthetic valve and the slidable wires.

Abstract: A heart valve delivery system is provided wherein a prosthetic valve is carried on a valve catheter inside a delivery sleeve. A step balloon protrudes from the delivery sleeve and provides a tapered surface for facilitating advancement through a body vessel. The step balloon also aids in crossing the leaflets of a native valve. After the prosthetic valve is positioned within the native valve, the delivery sleeve is retracted to expose the prosthetic valve. If necessary, the step balloon may be expanded to securely seat the prosthetic valve at the site of the native valve. The prosthetic valve is preferably coupled to the valve catheter by a plurality of flexible extension arms which allow the prosthetic valve to be collapsed after initial deployment such that the prosthetic valve may be repositioned if necessary.

Abstract: Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter.

Abstract: In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Abstract: A wound closure device comprises a first frame and a flexible tubular section connected to the first frame, the first frame implantable through a wound in a patient's skin into a lumen of a blood vessel with a portion of the tubular section extending out through the skin. The tubular section has a first portion and a second portion, a wall of the tubular section defining a coaxial inner bore. Twisting the first portion relative to the second portion of the tubular section closes the bore is closed in an area of the tubular section between the first and second portions, thereby closing the wound. Also disclosed is an embodiment for closing an opening in a heart, as well as a delivery device, systems, and methods.

Abstract: An apparatus and method for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Abstract: A method of delivering a prosthetic heart valve to a native aortic valve is disclosed. The prosthetic heart valve comprises a radially compressible and expandable metallic stent and a flexible valvular structure. A delivery system comprises a selectively steerable section and a pusher member extending through a central lumen of the steerable section. The prosthetic heart valve is compressed and inserted into a distal end portion of the delivery system. The delivery system and prosthetic heart valve are advanced through a femoral artery and around an aortic arch. A pull wire is actuated for selectively controlling a curvature of the steerable section during advancement around the aortic arch. The pusher member is advanced for ejecting the prosthetic heart valve from the delivery system into the native aortic valve, wherein the prosthetic valve self-expands after ejection.