Abstract: Methods, devices and systems for disabling and/or removing a mitral valve edge-to-edge repair device via minimally invasive, endovascular procedures. Additional procedures on a heart may sometimes become necessary after the installation of a mitral valve edge-to-edge repair device. To prepare for such additional procedures, the edge-to-edge repair device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart.

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: Medical device delivery system including a catheter, handle, lock line handle, and lock line. The catheter includes a proximal end portion and a distal end portion. The handle is coupled to the proximal end portion of the catheter. The lock line handle is releasably coupled to the handle and actuatable between a lock position and an unlock position. The lock line includes a first end portion fixedly coupled to the lock line handle, a second end portion releasably coupled to the lock line handle, and an intermediate portion configured to be releasably coupled to the medical implant disposed proximate the distal end portion of the catheter. Actuating the lock line handle from the lock position toward the unlock position increases tension on the lock line, and actuating the lock line handle from the unlock position toward the lock position decreases tension on the lock line.

Abstract: Fixation device for fixation of heart valve leaflets 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, and 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: An interventional tool includes a delivery catheter defining a central lumen and a plurality of peripheral lumens, at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter, and at least one line disposed within the at least one of the plurality of peripheral lumens, the at least one line being configured to actuate a medical device.

Abstract: Fixation system for fixation of leaflets of a heart valve including an implantable fixation device having a first arm and a second arm, a first proximal element moveable relative to the first arm between a first position and a second position, and a second proximal element moveable relative to the second arm between a first position and a second position. The fixation system includes a delivery device having a catheter, a first proximal element line and a second proximal element line, and a handle having a first and second proximal element line handles coupled to the first proximal element line and the second proximal element line, respectively. The handle can include an interlock moveable between an unlocked position and a locked position.

Abstract: A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter and a cutting mechanism routable through the guide catheter. The cutting mechanism includes a cutting arm and a plurality of grasping arms rotatably coupled to the cutting arm. The grasping arms are connected to the cutting arm via a central hinge and are actuatable between a closed position against the cutting arm and an open position where the grasping arms extend laterally away from the cutting arm by rotating about the hinge. Targeted cardiac leaflet tissue may be grasped between the cutting arm and the grasping arms and cut by a cutting element that is attached to or extends through the cutting arm.

Abstract: A fastening system and a deployment system for controlling translation and rotation of a deployment device are presented. A fastening system may comprise one or more components configured for arresting or restricting translation of a delivery catheter of a medical device, including a mitral valve fixation device such as the MitraClip®. A deployment system may comprise one or more components configured for locking rotation of a crimping cam to a slider to control deployment of a mitral valve fixation device.

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: According to one aspect, a mitral valve clip is introduced using a delivery system. The clip includes two arms at an angle relative to one another and a lock that prevents widening of the angle when the angle is below a locking threshold value, wherein the lock is in a passively disengaged state when the angle is above the locking threshold value. The lock is manually disengaged and the angle is expanded to a leaflet capture starting angle. The lock is returned to the passively disengaged state after the angle is expanded to the leaflet capture starting angle. The leaflets of a mitral valve are captured while the lock remains in the passively disengaged state. The clip is closed to a final closure angle by narrowing the angle while the leaflets are trapped. The lock transitions to an engaged state when the angle falls below the locking threshold value.

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: 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: Techniques are provided for candidate risk assessment for a mitral TEER procedure. A set of candidate anatomical features corresponding to a candidate for a mitral transcatheter edge-to-edge repair (TEER) procedure is received. A candidate feature vector based on the set of candidate anatomical features is generated. A classification engine is applied to the candidate feature vector, wherein the classification engine is trained to evaluate mitral TEER outcome. An outcome metric corresponding to a predicted mitral TEER success or a predicted mitral TEER failure for the candidate based on applying the classification engine is provided.

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 heart valve repair clip includes a stud, two arms operatively coupled to the stud and capable of transitioning between an open condition and a closed condition, and includes an indicator coupled to each of the two arms and moveable relative thereto.

Abstract: A fastening system and a deployment system for controlling translation and rotation of a deployment device are presented. A fastening system may comprise one or more components configured for arresting or restricting translation of a delivery catheter of a medical device, including a mitral valve fixation device such as the MitraClip®. A deployment system may comprise one or more components configured for locking rotation of a crimping cam to a slider to control deployment of a mitral valve fixation device.

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 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: 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 more lock lines being configured to engage with the implantable device to allow locking of the implantable device.

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.