Abstract: Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Abstract: The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft, a pair of proximal elements pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues.

Abstract: An interventional system that includes a delivery catheter that has a proximal end portion and a distal end portion. The interventional system includes a fixation device that has a distal fixation element, one or more reflective markers, and a proximal fixation element. The proximal fixation element is actuatable between an open position defining a graspable volume of space between the proximal fixation and the distal fixation element and a closed position. In the closed position the proximal fixation element is in a position proximal to the distal fixation element. The interventional system includes a sensor assembly that has a signal emitter configured to direct an emitted signal along an emission path toward the one or more reflective markers and a signal receiver configured to receive a reflected signal of the emitted signal off of the one or more reflective markers.

Abstract: Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for staged deployment of an implantable device to a target area. The delivery device includes a deployment handle and one or more lock lines extending from the deployment handle through the catheter to the implantable device, the one or ore lock lines being configured to engage with the implantable device to allow locking of the implantable device.

Abstract: A method of implanting a prosthetic atrioventricular valve into a native atrioventricular valve includes delivering a fixation device to the native valve, and applying the fixation device to engage and approximate free edges of two leaflets of the native valve. After applying the fixation device, the prosthetic valve is delivered to the native valve while the prosthetic valve is in a collapsed condition. The prosthetic valve is then be deployed into the native valve so that the prosthetic valve expands into engagement with the native valve. A transcatheter positioning device for an atrioventricular valve modification device delivery system is also provided. The positioning device comprises a positioning member having an undeployed configuration for delivery of the positioning device to an atrioventricular valve modification device delivery site in the heart of a patient and a deployed configuration for the positioning member to engage and reposition an object in the heart.

Abstract: A tunable fixation device for fixation of heart valve leaflets includes a central assembly, an arm moveably coupled to the central assembly, and a gripping element moveable relative to the arm to capture a native leaflet therebetween. The arm has a body portion and a wire frame coupled to the body portion. The wire frame has a first and second wire segment, and an interconnection portion interconnecting the first and second wire segments. The interconnection portion is slidingly engaged with the body portion. The first wire segment is configured to deform upon force applied to the second wire segment by sliding movement of the interconnection portion relative to the body portion, and the second wire segment is configured to deform upon force applied to the first wire segment by sliding movement of the interconnection portion relative to the body portion.

Abstract: A fixation device includes a primary unit having pair of distal elements and a pair of proximal elements, the pair of distal elements and the pair of proximal elements being configured to retain tissue, a secondary reinforcement coupled to the primary unit and transitionable between a first position spaced away from the primary unit and a second position nested about the primary unit, and a deployment shaft configured to actuate the secondary reinforcement between the first position and the second position. A method of treating a native valve includes providing a fixation device including a primary unit having a pair of distal elements and a pair of proximal elements configured to retain tissue, and a secondary reinforcement, and transitioning the secondary reinforcement from a first position to a second position to increase a stiffness of the fixation device.

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: Stabilizer for a medical delivery system is provided, wherein the medical delivery system has at least two portions translatable relative each other. The stabilizer includes a base and a sled coupled to the base. The sled includes a distal arm including a distal attachment for receiving a first portion of the medical delivery system, and a proximal arm including a proximal attachment for receiving a second portion of the medical delivery system. The sled is translatable relative to the base and the proximal attachment is translatable relative to the proximal arm.

Abstract: Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Abstract: Methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. A delivery device for staged deployment of an implantable device to a target area. The delivery device includes a deployment handle and one or more lock lines extending from the deployment handle through the catheter to the implantable device, the one or ore lock lines being configured to engage with the implantable device to allow locking of the implantable device.

Abstract: A tunable fixation device for fixation of heart valve leaflets includes a central assembly, an arm moveably coupled to the central assembly, and a gripping element moveable relative to the arm to capture a native leaflet therebetween. The arm has a body portion and a wire frame coupled to the body portion. The wire frame has a first and second wire segment, and an interconnection portion interconnecting the first and second wire segments. The interconnection portion is slidingly engaged with the body portion. The first wire segment is configured to deform upon force applied to the second wire segment by sliding movement of the interconnection portion relative to the body portion, and the second wire segment is configured to deform upon force applied to the first wire segment by sliding movement of the interconnection portion relative to the body portion.

Abstract: A mitral valve clip includes a stud, a lock, and two arms. The stud includes a shank, and the lock includes a frame relative to which the stud is translatable and into which the shank extends. The lock is able to prevent movement of the stud relative to the lock in at least one direction by locking engagement of the shank. The two arms are connected to the lock and the stud such that an angle between the arms depends on a location of the stud relative to the lock. The locking engagement of the shank that prevents movement of the stud relative to the lock in the at least one direction is only possible when the angle between the arms is below a predefined locking threshold.

Abstract: A fixation device for fixation of heart valve leaflets includes a central assembly and an arm moveably coupled to the central assembly. The arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween. The body portion has opposing body lateral sides, each body lateral side extending between the first end and the second end. Further, the body portion has a body portion width defined between the opposing body lateral sides. The fixation device further includes a size adapter attached to the arm, the size adapter having a maximum undeformed arm lateral cross-dimension defined between outer lateral edges of the size adapter. The ratio between the body portion width and the maximum undeformed arm lateral cross-dimension is at least about 1:1.8 to about 1:2.2. The fixation device further includes at least one gripping element.

Abstract: The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract.

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: A fixation device includes a first proximal element and a first distal element. The first proximal element has a gridded frame disposed between a first end portion and a second end portion and a plurality of frictional elements. The gridded frame has a plurality of axial struts and a plurality of transverse struts intersecting the axial struts to define a plurality of openings. At least some of the frictional elements extend from at least some of the transverse struts. The first distal element is disposed in opposition to the first proximal element and has a cavity disposed between a first end portion and a second end portion thereof. The cavity is configured to receive at least a portion of the gridded frame.

Abstract: A transapical removal device that can be deployed in a catheter procedure to capture for removal or alteration a mitral valve clip or heart tissue, such as the anterior leaflet of the mitral valve, and methods of use are disclosed. The removal device includes a delivery catheter configured to be deployed near a mitral valve using a guide catheter. The delivery catheter has a snare head at the distal end, which assumes a collapsed state during movement of the delivery catheter through the guide catheter and deployed state for capturing a mitral valve clip or anterior leaflet. The snare head has one or more ablation delivery catheters configured to ablate tissue surrounding the pre-positioned mitral valve clip or anterior leaflet. In some arrangements within the scope of the present disclosure, the removal device includes a deployment mechanism for deploying a new transcatheter valve into the mitral valve.

Abstract: The present disclosure relates to repair devices and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve in a collapsed configuration. The repair device includes a proximal disk and a distal disk joined by a neck section. The distal disk is deployed by passing it from the collapsed state to an expanded configuration on a first side of the tricuspid valve. The proximal disk is then deployed by passing it from the collapsed state to an expanded configuration on a second side of the tricuspid valve so as to grasp all three tricuspid valve leaflets between the deployed distal disk and the deployed proximal disk.