Methods and apparatus for a three-stage ventricular cardioversion and defibrillation therapy that treats ventricular tachycardia and fibrillation at low energy levels. An implantable therapy generator adapted to generate and selectively deliver a three-stage ventricular therapy and at least two leads operably each having at least one electrode adapted to be positioned proximate the ventricle of the patient. The device is programmed to deliver a three-stage therapy via both a far-field configuration and a near-field configuration of the electrodes upon detection of a ventricular arrhythmia. The three-stage therapy includes a first stage for unpinning of one or more singularities associated with the ventricular arrhythmia, a second stage for anti-repinning of the one or more singularities, both of which are delivered via the far-field configuration of the electrodes, and a third stage for extinguishing of the one or more singularities associated delivered via the near-field configuration of the electrodes.

Wearable devices are provided herein including wearable defibrillators, wearable devices for diagnosing symptoms associated with sleep apnea, and wearable devices for diagnosing symptoms associated with heart failure. The wearable external defibrillators can include a plurality of ECG sensing electrodes and a first defibrillator electrode pad and a second defibrillator electrode pad. The ECG sensing electrodes and the defibrillator electrode pads are configured for long term wear. Methods are also provided for using the wearable external defibrillators to analyze cardiac signals of the wearer and to provide an electrical shock if a treatable arrhythmia is detected. Methods are also disclosed for refurbishing wearable defibrillators. Methods of using wearable devices for diagnosing symptoms associated with sleep apnea and for diagnosing symptoms associated with heart failure are also provided.

The present invention provides both methods and devices for termination of arrhythmias, such as ventricular or atrial tachyarrhythmias. The device and method involves application of alternating current (AC) for clinically significant durations at selected therapeutic frequencies through the cardiac tissue to a subject experiencing arrhythmia. Methods are also provided to minimize or eliminate pain during defibrillation.

An implantable electrical stimulating device and system provides for a remote determination of the identity of the person in whom the stimulating device is implanted. The stimulating device may be a pacemaker, a defibrillator, another medical device or a non-medical device. The bases for the remote identification are (1) the comingling of (A) biologic identification information of the person linked to the stimulating device, and (B) information pertaining to a physiologic parameter (e.g. heart rate information) of that person, and (2) the modulation of the physiologic parameter by external information. Embodiments of the invention in which the stimulating device is external to the person are possible. By utilizing the apparatus providing for the remote identification of a person plus stimulating device, one aspect of secure communication—that based on reliable mutual identification of each participant in a communication—is achieved.

In one example, a cardiac monitoring system comprises a processor to receive a segment of an electrocardiogram (ECG) signal of a patient, and a memory to store the segment of the ECG. The processor is configured to identify QRS complexes in the segment of the ECG signal, generate a supraventricular (SV) template for SV complexes in the QRS complexes, identify SV complexes in the QRS complexes using the template, identify normal sinus rhythm (NSR) complexes in the segment of the ECG signal, obtain an atrial template for atrial waveforms in the NSR complexes, measure a range of a P-wave of the atrial waveforms from the NSR complexes, save the measured P-waves, and classify the identified SV complexes as either atrial fibrillation (AF) or supraventricular tachycardia (SVT) using the atrial template. Other examples and related methods are also disclosed herein.

Apparatus, systems, and methods are provided for monitoring AF episodes, delivering ATP pulses, and/or achieving electrical isolation of the left atrial appendage (LAA) of a patient's heart and/or preventing thrombus formation after electrical isolation. For example, devices are provided that may implanted from within the left atrium, e.g., to isolate the LAA, prevent thrombus formation within the LAA, facilitate endothelialization, and/or deliver pacing.

Systems, devices and methods for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body. A delivery and tether retraction system includes a handle for controlling a pusher and tether. The pusher may be moved a distance away from the implant without changing the orientation of the implant, while the tether is still attached to the implant. Severing the tether and proximally retracting a control on the hand piece by a distance causes the severed end to advance distally by at least about twice that distance. A loader includes a conical portion with guides and a reservoir for submerging the foam prior to loading and delivery.

Devices and methods are described for occluding the left atrial appendage (LAA). The device excludes the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. The implantable device is delivered via transcatheter delivery into the LAA and secured within the LAA. The implant comprises an expandable and compliant frame and an expandable and conformable tubular foam body carried by the frame. The device may have a thromboresistant cover at a proximal end and a thromboresistant coating on the foam body. The frame may have recapture struts inclining radially outwardly in the distal direction from a central hub. The frame may have axially extending side wall struts, with adjacent pairs of side wall struts joined at one or more apexes. Anchors extend from the frame to engage tissue. The anchors can also be reversible to allow retraction of the anchors and repositioning or retrieval of the device.

A device comprising a three-dimensional polymeric element and an electronic element integrated with the polymeric element is disclosed. The electronic element is made up of one or more electrode(s) each individually connectable to a measuring device and/or a controller, and each independently having a thin electrically-isolating layer deposited thereon such that the electrode is exposed to an environment surrounding the electrode at one or more pre-determined locations over the electrode. The device can include cells and/or tissue and/or a therapeutically active agent incorporated within the polymeric material. Processes of fabricating the device, systems for operating the device and methods utilizing same are also disclosed.

Methods and systems are provided for detecting arrhythmias in cardiac activity is provided. The method and systems are under control of one or more processors configured with specific executable instructions. The method and systems obtain a far field cardiac activity (CA) signal that includes a series of beats, the CA signal including paced events. The method and systems identify the paced events in the CA signals. The method and systems determine a score based on an amount of paced events and adjust at least one parameter of an atrial fibrillation (AF) detection process based on the score.