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: An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection.

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: Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Abstract: The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

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: An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection.

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: 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: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings.

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: 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: 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: 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: The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

Abstract: Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.

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: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings.

Abstract: A scaffold strut is shaped to improve hemocompatibility. The scaffold is made from a tube having variable wall thickness. Methods are disclosed for modifying the thickness of the tube in such a way as to achieve a reduced hemodynamic profile, but without significantly affecting strength properties in areas where stress concentrations exist when the scaffold is loaded.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings.