Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A medical system includes a generator configured to generate pulsed electric field (PEF) energy. A medical device is in electrical communication with the generator and has a plurality of electrodes configured to deliver the PEF energy to a target tissue to create electroporated regions in the target tissue. A delivery element tracking system is in communication with the generator and the medical device. The tracking system has processing circuitry configured to: measure a position of at least one of the plurality of electrodes prior to delivery of PEF energy to the target tissue with respect to the target tissue and correlate a PEF field distribution based on the delivery of PEF energy to the target tissue to determine or modify at least one metric of a therapeutic effect from the PEF delivery at positions other than the measured location of the plurality of electrodes.

Abstract: An example system for use in ablating target tissue includes memory configured to store anatomical and/or physiological information of a patient and processing circuitry communicatively coupled to the memory. The processing circuitry is configured to, based on the anatomical information and/or the physiological information, determine ablation parameters, the ablation parameters including a suggested positioning of at least energy delivery element of at least one catheter and/or an amount of energy to be delivered via the at least one energy delivery element to the target tissue during ablation. The processing circuitry is configured to output, for display, a representation of at least one of a suggested positioning of the at least one energy delivery element during the ablation, a representation of the target tissue, or a representation of the predicted tissue volume that will be ablated after delivery of ablation energy.

Abstract: Evaluating a cardiac lesion formed by an ablation procedure, by receiving, by processing circuitry and following conclusion of delivery of ablation energy, a bioelectrical signal from an electrode proximate to a target location of cardiac tissue for the cardiac lesion; determining, by the processing circuitry, one or more characteristics of the received bioelectrical signal in a frequency band of the received bioelectrical signal; and estimating, by the processing circuitry, an efficacy of the cardiac lesion based on a comparison of the determined amplitude of the bioelectrical signal and a threshold amplitude.

Abstract: A method and a medical device for determining efficacy of a pulsed electric field (PEF) ablation procedure are disclosed. According to one aspect, the method includes generating at least one pulsed electric field (PEF) pulse to be delivered to at least one electrode of a plurality of electrodes, the at least one electrode being at a distal end of a PEF ablation catheter and being positionable in proximity to a target region of tissue to be ablated. The method also includes determining an index of completeness indicative of a completeness of ablation of the target region of tissue based at least in part on a change in a parameter compared to an expected change in the parameter, the change in the parameter being caused at least in part on an extent of ablation of the target region.

Abstract: A lesion characterization process is disclosed. According to one aspect, a method includes obtaining measurements of at least one of an impedance magnitude, impedance phase, a temperature, and electrical properties of tissue of the lesion. The method further includes determining at least one lesion property including at least one of a depth of the lesion, percent transmurality of the lesion, lesion surface area and lesion volume based on at least one of the obtained measurements.

Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.

Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: A device, system, and method for mapping myocardial tissue, such as epicardial tissue on the right ventricle. A system for mapping myocardial tissue may include a mapping device having a distal portion that includes a distal assembly sized and configured to be positioned within the pericardial space. The distal assembly may include an expandable shell, at least one inflatable or expandable element within the expandable shell, and a mapping electrode assembly. Inflation or expansion of the at least one inflatable or expandable element, and therefore expansion of the expandable shell, within the pericardial space may provide sufficient force of the mapping electrodes against the myocardial tissue being mapped. The system may also include a delivery sheath with a retention element for controllably retracting the device within the sheath during delivery and removal of the device from the pericardial space.