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.

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.

Abstract: Devices, systems and methods for removal of a mitral valve clip and subsequent delivery of a mitral valve implantation in a mitral valve replacement procedure. A modular port accessory device having a distal connector configured to be compatible with corresponding connectors on an existing therapeutic device, wherein the port accessory can be selectively attached to a proximal end portion connector of a proximal end portion of a catheter assembly of an existing therapeutic device. The catheter assembly is introduced to a target site within the patient's anatomy, and remains in place throughout a multistep therapeutic procedure for use with other therapeutic devices, all while allowing hemostasis to be controlled during use ad interchange of multiple therapeutic devices.

Abstract: The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.

Abstract: A delivery system includes a delivery catheter that is releasably coupled to a fixation device and a delivery handle that is coupled to the delivery catheter. A lock control assembly of the delivery handle has a releasable lock line handle operable to lock and unlock components of the fixation device. The lock line handle has a shaft body and a lever arm that respectively define first and second openings. A lock line extending from the fixation device and through the delivery catheter has a first end portion fixedly coupled to the lock line handle and a second end portion that extends through the first and second openings. The lock line is free to move through the openings when the lever arm is in a first position and is secured when the lever arm is in a second position.

Abstract: Medical delivery system for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter, an inner guide catheter and an interventional catheter. The first deflection portion of the outer guide catheter is steerable to define a first outer-guide-catheter curve and the second deflection portion of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion of the inner guide catheter is steerable to define a first inner-guide-catheter curve.

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: Devices and methods for use in a cardiac valve repair procedure, particularly a tricuspid valve repair procedure. An interventional clip device includes a pair of distal elements rotatably joined to a coupling member, and a pair of proximal elements resiliently biased toward the distal elements to grasp tissue therebetween. The proximal elements include a plurality of adjustable tines moveable between a retracted configuration and an open configuration to avoid damage to tissue prior to engagement while allowing tines to enhance gripping to targeted tissue when open. A delivery system enables delivery of an interventional clip to a targeted cardiac valve, and includes a support structure for maintaining position relative to the cardiac valve.

Abstract: The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.

Abstract: Medical delivery system for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter, an inner guide catheter and an interventional catheter. The first deflection portion of the outer guide catheter is steerable to define a first outer-guide-catheter curve and the second deflection portion of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion of the inner guide catheter is steerable to define a first inner-guide-catheter curve.

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: A fixation device includes first and second distal elements and first and second proximal elements. The first and second proximal elements include a first elongate arm and a second elongate arm, respectively. The first and second elongate arms each include first and second side edges and plurality of frictional elements defining a plurality notches in the first and second side edges. The first and second proximal elements also each include first and second guard rails extending adjacent to and along the first and second side edges, respectively.

Abstract: An implantable fixation device includes fixation elements and gripping elements for fixating tissue. A stud is coupled to the fixation elements and is configured such that movement of the stud moves the fixation elements within a range of positions. A binding plate is configured to engage the stud to arrest its movement and to disengage the stud to allow its movement. A biasing element engages the binding plate and biases the binding plate into engagement with the stud. A harness with a single foot is engaged to the binding plate is configured such that tensioning the harness moves the binding plate in opposition to the bias of the biasing element so as to release the binding plate from the stud. Releasing tension on the harness returns the binding plate into engagement with the stud and secures the fixation elements in one position within the range of positions.