Abstract: A transseptal crossing needle has an elongate, flexible tubular body, having a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. The distal end has a radially inwardly extending annular recess. The tubular body has a first outside diameter proximally of the annular recess and a second, smaller outside diameter in the recess. An electrode tip has a proximally extending connector residing within the annular recess, and the electrode tip has a third outside diameter distally of the connector, which is greater than the first diameter. An insulation layer encloses the sidewall and the connector, and has an outside diameter approximately the same as the third diameter to provide a uniform outside diameter throughout a distal zone of the needle.

Abstract: A self-contained, battery powered transseptal crossing system is disclosed. An elongate, flexible electrically conductive needle body has a proximal end and a distal end. An insulation layer surrounds the sidewall and leaves exposed a distal electrode tip. A generator is configured to deliver RF energy to the electrode tip, and includes a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium.

Abstract: Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

Abstract: A self-contained, battery powered transseptal crossing system is disclosed. An elongate, flexible electrically conductive needle body has a proximal end and a distal end. An insulation layer surrounds the sidewall and leaves exposed a distal electrode tip. A generator is configured to deliver RF energy to the electrode tip, and includes a processos configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and / or confirm entry into the left atrium.

Abstract: A self-contained, battery powered transseptal crossing system is disclosed. An elongate, flexible electrically conductive needle body has a proximal end and a distal end. An insulation layer surrounds the sidewall and leaves exposed a distal electrode tip. A generator is configured to deliver RF energy to the electrode tip, and includes a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium.

Abstract: Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

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 depth sensing dilator system for dilating a penetration in a tissue plane includes an elongate flexible body, having a proximal end and a distal end. The body has a tapered dilator segment, and at least a first electrode on a distal end of the body. The system includes a processor and a user interface output device. The processor is configured to send a first signal to the output device when a change in impedance at the first electrode indicates that the first electrode has reached a predetermined relationship with the tissue plane.

Abstract: A self-contained, battery powered transseptal crossing system is disclosed. An elongate, flexible electrically conductive needle body has a proximal end and a distal end. An insulation layer surrounds the sidewall and leaves exposed a distal electrode tip. A generator is configured to deliver RF energy to the electrode tip, and includes a processor configured to take impedance measurements at the tip to confirm contact with the intra atrial septum and/or confirm entry into the left atrium.

Abstract: A transseptal crossing needle has an elongate, flexible tubular body, having a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. The distal end has a radially inwardly extending annular recess. The tubular body has a first outside diameter proximally of the annular recess and a second, smaller outside diameter in the recess. An electrode tip has a proximally extending connector residing within the annular recess, and the electrode tip has a third outside diameter distally of the connector, which is greater than the first diameter. An insulation layer encloses the sidewall and the connector, and has an outside diameter approximately the same as the third diameter to provide a uniform outside diameter throughout a distal zone of the needle.

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: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

Abstract: Catheters and methods for obtaining monophasic action potential (“MAP”) electrograms include a flexible catheter body defining a longitudinal axis, and a distal assembly affixed to the catheter body distal end defining a distal tip. The distal assembly has at least three MAP recording electrodes, and at least one reference electrode for determining reference potential. The recording electrodes are each positioned a radial distance from the longitudinal axis in at least three different radial directions, defining a recording geometry substantially having radial symmetry. The reference electrode is a longitudinal distance from the recording geometry. Optional features include a steerable catheter shaft, one or more radio-frequency ablation electrodes, and a dedicated pacing electrode. Different possible embodiments include a dome housing having the recording electrodes in a fixed spatial arrangement, and a distal loop assembly having an array of electrodes on at least three flexible loop elements.

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.