Abstract: A fixation device 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. The second end is moveable between a closed position and an open position. The body portion also includes opposing body lateral sides each extending between the first end and the second end and a body portion width defined between the opposing body lateral sides. The arm further includes first and second nondeformable wing extensions each extending laterally from a respective lateral side and having a lateral outer edge. A maximum arm width of the arm is defined between the outer lateral edge of the first wing extension and the outer lateral edge of the second wing extension. The fixation device further includes a gripping element moveable relative to the arm to capture a native leaflet therebetween.

Abstract: A fixation system includes a delivery device, a fixation device, and an optical coherence tomography (OCT) catheter. The delivery device includes a shaft that defines a lumen. The fixation device includes a first clamp, a second clamp, and a center portion. The center portion is releasably connected to a distal end of the shaft of the delivery device, and the first and second clamps define respective first and second lateral extents of the fixation device. The OCT catheter includes an imaging probe that comprises a first end, a second end, and a first lens assembly that is disposed at the second end of the imaging probe. In an assembled condition of the fixation system, the imaging probe extends through the lumen and out from the second end of the shaft such that the lens assembly is positioned between the first and second lateral extents of the fixation device.

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: 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: A fixation device for fixation of tissue includes a central element defining a central axis. The fixation device also includes a distal portion that includes an arm coupled to the central element and a leg operatively coupled to the arm. The arm is moveable to a selected position between a fully open position and a fully closed position. The leg is configured to move the arm to the selected position. The arm includes a contact portion for engaging tissue. The distal portion also includes a flexure portion configured to enable the contact portion in the selected position to move within a flex angle range between an undeformed contact portion angle relative to the central axis and a flexed contact portion angle relative to the central axis. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture tissue therebetween.

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 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: 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 system configured to detach an interventional implant from a cardiac valve includes a guide catheter and a capture mechanism routable through the guide catheter. The capture mechanism comprises a capture hypotube with a container portion/space configured to receive an interventional implant connected to cardiac valve tissue. The capture mechanism also includes a cutting arm axially moveable relative to the capture hypotube. The capture hypotube and the cutting arm each include cutting elements that are brought together upon actuation of the cutting arm to thereby cut the cardiac valve tissue surrounding the interventional implant to free the implant from the cardiac valve.

Abstract: A device configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter having a proximal end and a distal end, the guide catheter being positionable at a cardiac valve. The device may further include a cutting mechanism routable through the guide catheter and configured to extend from the distal end of the guide catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve. Finally, the device may comprise a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the cutting mechanism such that the at least one control is configured to provide selective actuation of the cutting mechanism.

Abstract: A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve. The system may also include a hook catheter having a proximal end and a distal end, the hook catheter configured to extend from the distal end of the guide catheter through a first orifice of the cardiac valve. Further, the system may comprise a cutting mechanism extending from the hook catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve. Finally, the system may include a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the cutting mechanism.

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: An interventional tool includes an outer sheath, a steerable sleeve disposed within the outer sheath and translatable relative thereto, an inner conduit disposed within the steerable sleeve and translatable relative thereto, and a stiffness-varying element disposed within the outer sheath and configured and arranged to transition the interventional tool between a first state having a first stiffness and a second state having a second stiffness, the first stiffness being greater than the second stiffness.

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: 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: 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: 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 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.