Abstract: A system for excising an implanted clip approximating opposed valve leaflets in a heart valve includes a capture catheter configured to be introduced proximate the valve leaflets on one side of the clip, a transfer catheter configured to be introduced proximate the valve leaflets on another side of the clip, and a cutting tool configured to be deployed between the capture and transfer catheters and to be engaged against tissue of at least one of the valve leaflets and to excise the clip. A removal catheter may optionally be used to remove the clip from the heart.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Abstract: The present disclosure describes interventional devices, systems, and methods for closing a regurgitant gap in a cardiac valve. Interventional devices are configured to be deployed between two previously placed implants or between a previously placed implant and a valve commissure. The interventional devices compress captured leaflet tissue and/or apply a tensioning force along the line of coaptation to assist in closing the gap and reducing regurgitant flow through the gap.

Abstract: Procedures may be performed on the heart after the installation of a mitral valve fixation device. In order to prepare the heart for such procedures, the fixation device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart. The fixation device may be partitioned so that one portion may remain attached to each leaflet of the mitral valve. In another example, the leaflets may be cut along the edges of the distal element(s) of the fixation device, so as to cut the fixation device from the leaflet(s). Systems and devices for performing such procedures endovascularly are disclosed. Fixation devices with improved access to a release harness are also disclosed.

Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: A tissue gripping device is formed from a shape-memory material, and has a base section, a first arm, and a second arm disposed opposite the first arm, each arm having a first end coupled to the base section and a free end extending from the base section. The arms of the tissue gripping device are configured to resiliently flex toward a relaxed configuration in a distal direction as the tissue gripping device is moved from a pre-deployed configuration toward a deployed configuration. The tissue gripping device is usable in a method for gripping tissue. The method includes positioning the tissue gripping device near target tissue and moving the tissue gripping device from a pre-deployed configuration toward a deployed configuration in order to grip the target tissue.

Abstract: System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, and a fixation device releasably coupled to the delivery catheter. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween.

Abstract: Disclosed is an instrument having an elongated shaft, a first member configured in the elongated shaft such that the first member can be deployed from a first portion of the instrument. The first member, when deployed, is configured over a tissue bridge within a heart, the tissue bridge having a clip or suture. A second member is also configured in the elongated shaft such that the second member is deployed from a second portion of the elongated shaft, wherein the second member, when deployed, is configured under the tissue bridge and the clip or suture. The elongated shaft is configured such that the second member, when deployed, moves towards the first member to yield a combined member which receives the tissue bridge and the clip or suture. The elongated shaft receives the combined member. The first member and/or the second member include a signal emitter to cut the tissue bridge.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

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: 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 invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Abstract: The present disclosure describes interventional devices, systems, and methods for closing a regurgitant gap in a cardiac valve. Interventional devices are configured to be deployed between two previously placed implants or between a previously placed implant and a valve commissure. The interventional devices compress captured leaflet tissue and/or apply a tensioning force along the line of coaptation to assist in closing the gap and reducing regurgitant flow through the gap.

Abstract: Valve devices for replacement of mitral valves while preserving valvular and subvalvular mitral valve apparatus. The valve device may be configured as a double orifice valve replacement device, and may include an anchoring and manifold assembly coupleable to a delivery catheter. The assembly may include means for anchoring the device to the mitral valve or to a fixation device already attached to the mitral valve. A peripheral ring anchoring system secured to the assembly may include at least one expandable anchoring ring that is expandable within an orifice of the mitral valve so as to surround the orifice perimeter. A helical suture may be helically disposable about the ring, securing the ring to adjacent leaflet tissue. A trap door valve including a trap door body that seals against the anchoring ring during systole and unseals during the diastolic portion of the cardiac cycle may be provided.

Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

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: System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion.