Abstract: A split-frame cardiac valve (20) is configured to assume a radially compressed configuration for transcatheter delivery and a radially expanded configuration for anchoring to a native cardiac valve annulus. The split-frame cardiac valve (20) includes circumferential frame segments (22) including respective stents (24) and prosthetic leaflets (30). When the split-frame cardiac valve (20) is in the radially expanded configuration: (a) each of the stents (24) surrounds less than 360 degrees of a central longitudinal axis (26) of the split-frame cardiac valve (20), (b) the circumferential frame segments (22) are slidingly coupled to one another so as to be axially slidable with respect to one another in and out of axial alignment with one another, and (c) when the circumferential frame segments (22) are axially aligned with one another, the stents (24) collectively define a tubular stent (32) that entirely surrounds the central longitudinal axis (26).

Abstract: A valve-delivery-assist tool (20, 120, 220, 320) is provided for use during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve. The valve-delivery-assist tool (20, 120, 220, 320) includes a delivery catheter (22); an aortic-valve cusp guide (24), which deflects laterally upon being released from the delivery catheter (22); and a conduction-tissue protector (26, 126), which includes a sheet (28, 128) and expands upon being released from a distal end (29) of the delivery catheter (22).

Abstract: The present invention describes systems and methods for treating tricuspid valve regurgitation and mitral valve regurgitation. The treatment includes a systems and method of modifying the tricuspid or mitral valve by attaching a device in two locations in the valve annulus and pulling them toward each other to stop valve regurgitation by modifying the leaflets of the valve.

Abstract: An ablation system comprises: an ablation catheter and a console. The ablation catheter comprises: a shaft including a proximal end, a distal portion and a distal end; an ablation element configured to deliver energy to tissue; and a force maintenance assembly comprising a force maintenance element and configured to control and/or assess contact force between the ablation element and cardiac tissue. The console is configured to operably attach to the ablation catheter and comprises: an energy delivery assembly configured to provide energy to the ablation element. Methods of ablating tissue are also provided.

Abstract: The present invention describes systems and methods for treating mitral valve regurgitation. The treatment includes a systems and method of modifying the mitral valve by attaching a device to each leaflet and pulling them toward each other to stop mitral valve regurgitation.

Abstract: The present invention describes systems and methods for treating mitral valve regurgitation. The treatment includes a systems and method of modifying the mitral valve by attaching a device to each leaflet and pulling them toward each other to stop mitral valve regurgitation.

Abstract: The present invention describes systems and methods for treating mitral valve regurgitation. The treatment includes a systems and method of modifying the mitral valve by attaching a device to each leaflet and pulling them toward each other to stop mitral valve regurgitation.

Abstract: The present invention describes systems and methods for treating a hole in the septum, such as a patent foramen ovale or an atrial septal defect, with a closure implant designed to fluidly seal the hole to prevent blood from flowing between the right atrium to the left atrium. The closure implant includes two structures positioned on opposite sides of the hole in septum configured to close and seal the hole. The first structure is an expandable petal anchor having multiple petal groups with multiple petals of different sizes and/or shapes made of shape memory wire configured to be positioned on a distal side of the hole in the septum wall, and the second structure is a braided disk made of shape memory mesh positioned the proximal side of the hole in the septum wall, opposite the petal anchor. The braided disk is sized to cover the hole once it is expanded. The petal anchor is designed to pull and compress the braided disk against the septum wall to cover and fluidly seal the hole.

Abstract: The present invention describes systems and methods for treating the left atrial appendage with an implant to fluidly seal the left atrial appendage and prevent blood from flowing from the left atrial appendage to the left atrium. The closure implant includes a braided disk, a proximal petal anchor and a distal petal anchor positioned on an implant shaft. The braided disk includes two diameters: a proximal diameter sized to engage a wall area in the left atrium around the LAA ostium; and a distal diameter sized to fit within the LAA ostium. The proximal and distal petal anchors include asymmetrical petals arranged like the petals of a flower configured to engage the wall of the LAA to anchor the implant. The implant is designed to be delivered to the heart using a catheter-based delivery system.

Abstract: A system for treating and/or monitoring a medical condition of a patient comprises: an implant configured to be inserted into a body space of the patient, such as the left atrial appendage. The implant comprises a frame or ring configured to engage tissue of the patient proximate the body space. Methods of treating and/or monitoring a medical condition of a patient are also provided.

Abstract: A coaptation-assist device (20, 120A, 120B, 120C, 320A, 320B, 420, 720) is provided for treating a native atrioventricular valve, including a loop-shaped ventricular anchor (30, 130, 330, 430, 730) which includes an anchor-loop wire loop (50, 150, 350, 450, 750), which defines at least a portion of a border of the loop-shaped ventricular anchor, and is configured to be positioned in a ventricle, extending between a ventricular apical area and a subannular surface of a target native leaflet, and to remain anchored in position against surrounding anatomy, including the subannular surface, a ventricular wall, and the ventricular apical area. A neo-leaflet (32, 132A, 132B, 132C, 332A, 332B, 332A, 332B, 432, 732) is supported by the loop-shaped ventricular anchor and is configured to at least partially replace function of the target native leaflet by providing a surface of coaptation (34, 434, 734) for one or more opposing native leaflets that oppose the target native leaflet. Other embodiments are also described.

Abstract: An ablation system comprises: an ablation catheter and a console. The ablation catheter comprises: a shaft including a proximal end, a distal portion and a distal end; an ablation element configured to deliver energy to tissue; and a force maintenance assembly comprising a force maintenance element and configured to control and/or assess contact force between the ablation element and cardiac tissue. The console is configured to operably attach to the ablation catheter and comprises: an energy delivery assembly configured to provide energy to the ablation element. Methods of ablating tissue are also provided.

Abstract: An intravascular catheter system for treating a condition in a body includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The first inflatable balloon is positioned near a distal end of the catheter shaft. The first inflatable balloon moves between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon away from the maximum circumference of the first inflatable balloon. In some embodiments, the plurality of electrodes are attached to the inner surface of the first inflatable balloon. In various embodiments, the intravascular catheter system can also include two or more flex circuits that substantially face one another when the first inflatable balloon is in the substantially deflated state.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a compensation assembly for a balloon catheter system. The balloon catheter system may include a balloon catheter having a guidewire lumen and a balloon that is secured to the guidewire lumen with the balloon being movable between a deflated state and an inflated state.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having hi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate. Optional features include a series of thermocouples for monitoring local temperatures.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate. Optional features include a series of thermocouples for monitoring local temperatures.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate.

Abstract: Medical devices, systems, and methods for treating patients with tissue ablation include catheter systems having bi-modal steering mechanisms, which are capable of both linear and loop ablation. In other words, the catheter system may have two different steering modes: two-dimensional and three-dimensional. In the first and second steering modes, the steering actuator may cause one or more portions of the catheter shaft to bend in different planes. A steerable ablation catheter may include treatment elements such as electrodes at its distal end and along the catheter shaft, each of which may map, pace, and ablate. Optional features include a series of thermocouples for monitoring local temperatures.