Abstract: Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.

Abstract: Catheter assembly with a coaptation aid for repair of leaflets of a heart valve includes an elongate catheter shaft adapted to be positioned transvascularly proximate a heart valve and a lever coupled to the catheter shaft. The lever has a hinge to transition the lever between an elongate delivery configuration generally aligned longitudinally with the catheter shaft and a deployed configuration extending transversely from the catheter shaft. The lever also includes an atraumatic tip at a distal end thereof and adapted to contact a distal side of a native leaflet of the heart valve when the catheter shaft is positioned proximate the heart valve and the lever is in the deployed configuration, and an actuation assembly coupled to the lever to remotely transition the lever between the delivery configuration and the deployed configuration. Method for fixation of native leaflets of a heart valve using the catheter assembly also disclosed.

Abstract: Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.

Abstract: Devices and methods for removing a valve clip which is pre-positioned on a heart leaflet, the valve clip including a delivery catheter having a distal end portion configured to be positioned near a heart valve; a grasping tool deployable from the distal end portion of the delivery catheter, the grasping tool configured to grasp and manipulate a valve clip from an implanted condition to an elongated condition, wherein the valve clip in the elongated condition has an elongated width less than an implanted width of the valve clip in the implanted condition; and a removal tool extendable relative to the distal end portion of the delivery catheter, the removal tool configured to at least partially surround the valve clip in the elongated condition and to remove the valve clip from the heart valve leaflet.

Abstract: Catheter assembly with a coaptation aid for repair of leaflets of a heart valve includes an elongate catheter shaft adapted to be positioned transvascularly proximate a heart valve and a lever coupled to the catheter shaft. The lever has a hinge to transition the lever between an elongate delivery configuration generally aligned longitudinally with the catheter shaft and a deployed configuration extending transversely from the catheter shaft. The lever also includes an atraumatic tip at a distal end thereof and adapted to contact a distal side of a native leaflet of the heart valve when the catheter shaft is positioned proximate the heart valve and the lever is in the deployed configuration, and an actuation assembly coupled to the lever to remotely transition the lever between the delivery configuration and the deployed configuration. Method for fixation of native leaflets of a heart valve using the catheter assembly also disclosed.

Abstract: Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled to the central assembly. The at least one arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides. The at least one arm further includes first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension.

Abstract: Delivery system for fixation device, including guide catheter with proximal end portion having proximal end port, distal end portion having distal end port, and inner surface defining inner lumen extending in fluid communication between proximal end port and distal end port. Delivery catheter extending through the inner lumen to define annular space between outer surface of the delivery catheter and inner surface of the guide catheter. A pressure sensor proximate the proximal end portion in fluid communication with the annual space to monitor fluid pressure. The distal end portion of the guide catheter includes flow passages in fluid communication between an exterior of the distal end portion and the annular space.

Abstract: Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.

Abstract: Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled to the central assembly. The at least one arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position, the body portion having opposing body lateral sides, each body lateral side extending between the first end and the second end, the body portion having a body portion width defined between the opposing body lateral sides. The at least one arm further includes first and second nondeformable wing extensions, each wing extension extending laterally from a respective lateral side, each wing extension having a lateral outer edge, wherein a maximum arm width is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension.

Abstract: A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Abstract: Fixation device for fixation of leaflets of a heart valve includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm. The fixation device further includes a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis.

Abstract: Fixation device for fixation of leaflets of a heart valve, the fixation device including a central element defining a central axis. The fixation device further includes a distal portion including at least one arm coupled to the central element, wherein the at least one arm is moveable to a selected position between a fully open position and a fully closed position. The distal portion further includes at least one leg operatively coupled to the at least one arm and configured to move the at least one arm to the selected position between the fully open position and the fully closed position. The at least one arm includes a contact portion configured to engage native heart valve tissue, the contact portion defining a contact portion axis.

Abstract: A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Abstract: Fixation device for fixation of leaflets of a heart valve includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm. The fixation device further includes a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: System for fixation of native leaflets of a heart valve including an implantable fixation device including a center portion defining a longitudinal axis. The implantable fixation device further includes a first distal assembly having a first distal strut pivotally-coupled with the center portion and a first distal element pivotally-coupled with the first distal strut. The first distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a second distal assembly having a second distal strut pivotally-coupled with the center portion and a second distal element pivotally-coupled with the second distal strut. The second distal assembly is configured to move between a closed position and an extended position. The implantable fixation device further includes a locking mechanism configured to lock the first distal assembly and second distal assembly in a selected locked position between the closed position and the extended position.

Abstract: Fixation device for engaging tissue including a pair of fixation elements, each fixation element has a first end and a second end opposite the first end, the first ends are moveable between a closed position and an open position. The fixation device further includes a pair of gripping elements. Each gripping element is moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween. The fixation device further includes a central portion operatively connected to each gripping element at a respective central portion-gripping element interface. The central portion has at least one distal end and a width “W1” proximate the distal end. Each of the gripping elements has a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end.

Abstract: Fixation device for engaging tissue including a pair of fixation elements, each fixation element has a first end and a second end opposite the first end, the first ends are moveable between a closed position and an open position. The fixation device further includes a pair of gripping elements. Each gripping element is moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween. The fixation device further includes a central portion operatively connected to each gripping element at a respective central portion-gripping element interface. The central portion has at least one distal end and a width “W1” proximate the distal end. Each of the gripping elements has a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end.

Abstract: Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled relative to the central assembly. The at least one arm includes a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position. The deformable frame further includes first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, and each flex portion having an outer lateral edge. The at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition.

Abstract: Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.