Abstract: A stabilizer system for supporting a medical device includes a platform and a stabilizer body positioned on the platform and being slidably translatable about the platform. The platform includes a translation actuator configured to engage with a receiving member of the stabilizer body. Actuation of the translation actuator passes a force to the receiving member of the stabilizer body and causes the stabilizer body to translate relative to the platform. The stabilizer body includes a base and one or more support wings extending from the base to support a medical device. A straddle actuator is coupled to a support wing and is configured to engage with the medical device. Actuation of the straddle actuator passes a force to the medical device and causes at least a portion of the medical device to translate relative to the stabilizer body.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

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: 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: 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: An interventional curvature device for temporarily adjusting the structure of a heart during a heart valve repair procedure in order to enhance the effectiveness of the heart valve repair procedure. The curvature device is adjustable between a collapsed configuration with a profile suitable for delivery of the device to a coronary sinus and great cardiac vein of a patient, and an expanded configuration for lodging of the device at the coronary sinus and great cardiac vein. The curvature device has a distal section that anchors within the great cardiac vein, and a proximal section that anchors within the coronary sinus. A tether is coupled to the distal end of the device and extends through the device and past the proximal end. An increase in tension in the tether increases the curvature of the device.

Abstract: Fixation device for engaging tissue including a pair of fixation elements, each fixation element has a first end and a second end opposite the first end, the first ends are moveable between a closed position and an open position. The fixation device further includes a pair of gripping elements. Each gripping element is moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween. The fixation device further includes a central portion operatively connected to each gripping element at a respective central portion-gripping element interface. The central portion has at least one distal end and a width “W1” proximate the distal end. Each of the gripping elements has a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end.

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: 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: 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 grasping assembly movable between a first position and a second position and a distal grasping assembly movable between a third position and a fourth position. An actuator rod operatively connected to each of the proximal grasping assembly and the distal grasping assembly so that distal movement of the actuator rod simultaneously moves the proximal grasping assembly proximally and the distal grasping assembly distally.

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: 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: An interventional device for cutting tissue at a targeted cardiac valve, such as a mitral valve. The interventional device includes a catheter having a proximal end and a distal end. A cutting mechanism is positionable at the distal end, such as by routing the cutting mechanism through the catheter to position it at the distal end. The cutting mechanism includes one or more cutting elements configured for cutting valve tissue when engaged against the tissue. A handle is coupled to the proximal end of the catheter and includes one or more controls for actuating the cutting mechanism.

Abstract: Fixation device for engaging tissue including a pair of fixation elements, each fixation element has a first end and a second end opposite the first end, the first ends are moveable between a closed position and an open position. The fixation device further includes a pair of gripping elements. Each gripping element is moveable with a respective fixation element and disposed in opposition to at least a portion of the respective fixation element to capture tissue therebetween. The fixation device further includes a central portion operatively connected to each gripping element at a respective central portion-gripping element interface. The central portion has at least one distal end and a width “W1” proximate the distal end. Each of the gripping elements has a free end opposite its respective central portion-gripping element interface and a length “L1” defined between the respective central portion-gripping element interface and the free end.

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: 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: Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.

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.

Abstract: Catheter assembly with a coaptation aid for repair of leaflets of a heart valve includes an elongate catheter shaft adapted to be positioned transvascularly proximate a heart valve and a lever coupled to the catheter shaft. The lever has a hinge to transition the lever between an elongate delivery configuration generally aligned longitudinally with the catheter shaft and a deployed configuration extending transversely from the catheter shaft. The lever also includes an atraumatic tip at a distal end thereof and adapted to contact a distal side of a native leaflet of the heart valve when the catheter shaft is positioned proximate the heart valve and the lever is in the deployed configuration, and an actuation assembly coupled to the lever to remotely transition the lever between the delivery configuration and the deployed configuration. Method for fixation of native leaflets of a heart valve using the catheter assembly also disclosed.

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.