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: A mitral valve repair system includes a delivery sheath, a mitral valve repair device, and an actuator. The mitral valve repair device is disposed in the delivery sheath in an extended condition. The mitral valve repair device is movable out of the delivery sheath while in the extended condition. The actuator is coupled to the mitral valve repair device, such that retracting the actuator reduces a length of the mitral valve repair device from the extended condition.

Abstract: A mitral valve repair system includes a delivery sheath, a mitral valve repair device, and an actuator. The mitral valve repair device is disposed in the delivery sheath in an extended condition. The mitral valve repair device includes a pair of barbed clasps. The barbed clasps are in a closed condition while the mitral valve repair device is in the extended condition in the delivery sheath.

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: 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: Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

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 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 apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: Tools and methods are provided for delivering a device to a native valve of a patient's heart. A catheter can include a flexible tube, a plurality of links, and a control wire. Applying tension to the control wire pulls on the links, which causes links to bend the flexible tube.

Abstract: A pair of paddles are moved laterally away from one another in an exemplary method of repairing a native valve of a patient during a non-open-heart procedure. After the paddles are moved laterally away from one another, first and second gripping members are moved from an open position to a closed position to grasp valve leaflets. The paddles are then moved laterally toward one another. A cam can be used to move the paddles away from one another.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open-heart procedure has a delivery device and a valve repair device. The valve repair device is configured to be delivered through a lumen of the delivery device and to attach to a native valve of a patient. The valve repair device has first and second paddles and first and second gripping members. The first and second paddles are movable between an open position and a closed position. The first gripping member is attached to the first paddle and the second gripping member is attached to the second paddle. The gripping members are configured to attach to the native valve of the patient. A gripper control mechanism is configured to separately move the first and second gripping members.

Abstract: An exemplary recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure has a delivery device, a valve repair device, and a tethering line. The delivery device has a catheter and a coupler. The valve repair device is configured to be delivered through the catheter and attach to a native valve of a patient. The valve repair device includes a coaption element, a proximal collar, and first and second paddles. The first and second paddles are connected to the coaption element. The coupler is releasably connected to the proximal collar. The tethering line connects the valve repair device to the delivery device for recapturing the valve repair device.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles, and barb portions. The barb portions extend directly from at least one of the coaption element and the pair of paddles.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open heart procedure includes a delivery device and a valve repair device. The valve repair device includes a pair of gripping members that are configured to attach to the native valve of the patient. A gripper control mechanism is configured to independently engage and move each of the gripping members.

Abstract: An exemplary valve repair device is released from tissue of a valve of a patient by applying tension to a movable arm of a clasp in a retraction direction. A fixed arm of the clasp is attached to an inner paddle portion of a paddle of the valve repair device. The inner paddle portion is connected to an outer paddle portion of the paddle of the valve repair device. Pulling the moveable arm of the clasp flexes the inner paddle portion to allow the moveable arm to move in the retraction direction and thereby release the clasp from the valve tissue.

Abstract: An exemplary valve repair device for repairing a valve of a patient has a paddle, and a clasp. The clasp has a fixed arm attached to the paddle and a moveable arm. The moveable arm includes barbs that are spaced apart from a connection between the moveable arm and the fixed arm. The moveable arm is movable between open and closed positions relative to the fixed arm. The moveable arm has a weakened portion between the barbs and the connection between the moveable arm and the fixed arm. Applying tension to the movable arm in a retraction direction stretches the moveable arm and moves the barbs in the retraction direction.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a cap, and a paddle. The paddle has an inner paddle portion and an outer paddle portion. The inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric. The outer paddle portion is connected to the cap. The cap is moveable away from the inner paddle portion to open the paddle.