Abstract: Systems apparatuses and assemblies for tilting and flushing delivery systems. The assembly can include an implant, a delivery system, and packaging. The delivery system can include a catheter, a control handle, and a distal part coupled to the implant. The control handle can extend from a proximal end of the catheter. The packaging can include a first portion, a second portion and a lateral connecting the first portion and the second portion. The first portion can contain the implant. The second portion can contain the handle. The lateral line can enable the first portion to be rotated relative to the second portion. Rotating the first portion can form the packaging into a tilt stand in which the handle is tilted to facilitate flushing of the delivery system and the implant via the fluid port.

Abstract: A valve repair device for repairing a native valve of a patient. The valve repair device includes a base, a first paddle, a second paddle, and a rack and pinion mechanism. The first paddle is pivotally connected to the base. The second paddle is pivotally connected to the base. The rack and pinion mechanism is coupled to the first paddle and the second paddle. The rack and pinion mechanism is configured to move the first paddle and the second paddle between an open position and a closed position.

Abstract: A method and system for implanting and rereleasing an implantable device for a native valve of a patient's heart includes a delivery catheter, a clasp, and a clasp actuation line. The clasp actuation line extends from the delivery catheter and passes through an opening of the clasp. A looped end of the first clasp actuation line is releasably coupled to at least one of the delivery catheter and the implantable device.

Abstract: In one example, 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. A size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Abstract: Clasps for valve repair devices, valve repair devices and systems are configured to detect proper valve leaflet insertion. The clasp and/or device can have a fixed arm, a moveable arm and a hinge portion hingeably connecting the moveable arm to the fixed arm. The clasp and/or device can include a first marker disposed on the movable arm and an indicator comprising a second marker. The clasp and/or device can be configured such that the first marker is adjacent to the second marker when the movable arm is in the closed position and a leaflet of a native valve is not inserted to a minimum insertion depth in the clasp and the first marker and the second marker are spaced apart when the movable arm is in the closed position and the leaflet of the native valve is inserted to the minimum insertion depth in the clasp.

Abstract: Clasps for valve repair devices, valve repair devices and systems are configured to detect proper valve leaflet insertion. The device can have a paddle and a movable clasp arm. The movable clasp arm can have first and second spaced apart sides. The paddle and the movable clasp arm are moveable to form an opening between the movable clasp arm and the paddle. The device can include an indicator arm disposed between the first and second spaced apart sides of the movable clasp arm. The indicator arm is moveable in the opening to indicate whether a leaflet of the native valve is inserted into the opening between the paddle and the movable clasp arm to at least a minimum desired insertion depth.

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: 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.