Abstract: A catheter assembly includes a handle assembly, a steerable catheter, and an actuation element. The handle assembly includes a handle housing, a guide member, a follower, and a driver. The driver engages the follower to cause the follower to move relative to the guide member. The actuation element is connected to the follower and the steerable catheter. Movement of the follower relative to the guide member causes the actuation element to engage the steerable catheter to move the steerable catheter between the flexed configuration and the unflexed configuration.

Abstract: Disclosed are embodiments of replacement heart valves. Embodiments may include a collapsible and expandable frame comprising rows of cells. The frame may include a plurality of axial connection portions extending between top ends and bottom ends of the cells, wherein each axial connecting portion is shaped to bend for accommodating temporary changes in cell height during non-uniform compression of the replacement heart valve. Frames having these features are advantageous when advancing a replacement heart valve through a funnel-shaped compression tool. The axial connection portions are sufficiently flexible to accommodate changes in frame shapes during compression while also being sufficiently resilient for enhancing the structural integrity of the frame in the fully deployed state. The replacement heart valves are preferably dual-frame heart valves, wherein the axial connection portions form a portion of an inner frame and wherein an outer frame is provided for engaging tissue and forming a seal.

Abstract: A valve repair device includes a first paddle, a second paddle, a spacer, a first gripping member, and a second gripping member. The first paddle and the second paddle are configured to move between a closed position and an open position. The spacer is disposed between the first paddle and the second paddle. The first gripping member is disposed between the first paddle and the spacer. The second gripping member is disposed between the second paddle and the spacer. The first paddle and the first gripping member are configured to capture a first native valve leaflet. The second paddle and the second gripping member are configured to capture a second native valve leaflet.

Abstract: A prosthetic heart valve includes a self-expanding frame and a plurality of prosthetic valve leaflets positioned within an interior of the frame. Ventricular anchors extend from a downstream portion of the frame and are shaped for capturing native leaflets. Barbs are preferably provided along an outer surface of the frame for enhanced fixation. The self-expanding frame may include an inner frame for supporting the prosthetic valve leaflets and an outer frame for sealing against the tissue of the native heart valve. The inner and outer frames may be attached via a flexible intermediate component for allowing the inner frame to move relative to the outer frame. The outer frame may be more conformable than the inner frame and the outer frame may include axial recesses for receiving the ventricular anchors and thereby reducing profile after implantation. The prosthetic heart valve is preferably sized to replace a native tricuspid valve.

Abstract: Systems for replacing the function of a native atrioventricular valve are described. The systems can include a prosthetic heart valve including a self-expanding frame and a plurality of leaflets. The systems can include a delivery catheter having an elongate shaft for advancing the prosthetic heart valve through a patient's vasculature to the native atrioventricular valve, the elongate shaft including a capsule along a distal end portion of the elongate shaft for maintaining the prosthetic heart valve in a compressed state. A tether assembly can extend through the elongate shaft of the delivery catheter and can include loop portions. A release assembly can include a plurality of flexible release tethers that are retractable for removal from the loop portions and thereby allowing the tether assembly to be released from the prosthetic heart valve.

Abstract: Catheterization methods and apparatuses allow sensing of pressures inside the heart and for removing air from catheters. A delivery system can use the same components that are used to deliver a valve repair or replacement device to measure the pressure in the atrium or other heart chamber. A pressure sensor can be included in one of the catheters of the delivery system or pressure can be sensed through the same port that is used to flush a catheter. The delivery system can be inserted into the heart, delivering the valve repair or replacement device to the native valve, such as the mitral valve, the tricuspid valve, the aortic valve, or the pulmonary valve.

Abstract: Clasps for valve repair devices, valve repair devices and systems are configured to detect proper valve leaflet insertion. The device and systems can have a plurality of paddles and a movable clasp corresponding to each of the paddles. An insertion depth indicator is configured to provide an indication of an insertion depth of a leaflet of a native valve between each paddle and the corresponding moveable clasp arm. The insertion depth indicator comprises at least one sensor.

Abstract: 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. The prosthetic device can be movable between multiple configurations. Each anchor is configured to be positioned behind a native valve leaflet of the two native leaflets such that the native leaflet is captured between the anchor and the spacer body.

Abstract: Catheterization methods and apparatuses allow sensing of pressures inside the heart and for removing air from catheters. A delivery system can use the same components that are used to deliver a valve repair or replacement device to measure the pressure in the atrium or other heart chamber. A pressure sensor can be included in one of the catheters of the delivery system or pressure can be sensed through the same port that is used to flush a catheter. The delivery system can be inserted into the heart, delivering the valve repair or replacement device to the native valve, such as the mitral valve, the tricuspid valve, the aortic valve, or the pulmonary valve.

Abstract: In a method of treating an atrioventricular valve, a sealing element is deployed in a native atrioventricular valve of a heart at a position between native atrioventricular valve leaflets to contact the native atrioventricular valve leaflets. The sealing element is controlled by user input to both radially expand and radially reduce the sealing element while at the position between the native atrioventricular valve leaflets. At least one of the native atrioventricular leaflets is secured between an inner anchor member and an outer anchor member to support the sealing element at a desired position between the native atrioventricular valve leaflets.

Abstract: Valve repair devices and valve repair systems for repairing a native valve of a patient are configured to reduce a gap in the native valve of the patient when the valve repair device is attached to the native valve. The valve repair devices can include a spacer. The valve repair devices can be closes to attach the device to leaflets of the heart valve.

Abstract: An implantable device includes an adjustable spacer and at least one anchor. The adjustable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween. An clastic or stretchable cover is part of or disposed over the adjustable spacer.

Abstract: An implantable prosthetic device has a coaptation element. At least a portion of the coaption element is formed from the strip of material. A pair of paddles are connected to the coaption element. The paddles are movable between an open position and a closed position. The paddles are configured to attach to the native valve of the patient.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The clasps include a fixed arm and a plurality of movable arms. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

Abstract: A prosthetic heart valve configured to be expanded within a native valve annulus, engage surrounding tissue, and constricted tissue inward to enhance contact between the tissue and the valve. The heart valve may have a structural valve stent with an outer constricting structure having tissue-engaging members or anchors. The constricting structure may be intrinsic or extrinsic. One intrinsic version includes a plurality of arms that are arranged to constrict inward toward a central valve portion, or a fabric structure with tissue anchors and surrounding an inner valve member may be cinched to pull the tissue inward. The anchors may engage tissue around the annulus in the atrium, or surround leaflets in the ventricle, or grasp leaflets from within.

Abstract: Apparatuses, systems, and methods for prosthetic valves. The prosthetic valves disclosed herein may be utilized for improved deployment, sealing, and anchoring to an implantation site. An implantation site may comprise a native heart valve or another implantation site in examples. Examples of prosthetic valves may include a proximal tensioning body positioned at a proximal portion of the prosthetic valve and a distal tensioning body positioned at a distal portion of the prosthetic valve. A sealing skirt may have a proximal end portion coupled to the proximal tensioning body and a distal end portion coupled to the distal tensioning body. The sealing skirt may be tensioned by the proximal tensioning body and the distal tensioning body and deflectable to conform to a shape of the native valve.

Abstract: An implantable device includes an adjustable spacer and at least one anchor. The adjustable spacer is configured to be positioned between native heart valve leaflets to reduce regurgitation therebetween. The adjustable spacer can comprise a first side and a second side opposite the first side. Each side can be adjustable between a first width and a second width. Each side can be independently moved between the first width and the second width. The adjustable spacer can be made from a sponge material.

Abstract: A valve repair device for repairing a native valve of a patient can include a coaptationm element. The valve repair device can include a pair of paddles. The coaption element can comprise a fabric. The pair of paddles can be connected to the coaption element. The paddles are movable between an open position and a closed position. The paddles are configured to attach to the native valve of the patient.

Abstract: An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve. Other embodiments are also described.