Abstract: Patient treatment systems and methods for sensing cardiac depolarization and/or stimulating the carotid sinus nerve are disclosed herein. Exemplary patient treatment systems can include a neuromodulator and an implantable signal delivery device electrically coupleable to the neuromodulator. The signal delivery device comprises a lead body including a first region, a second region positionable over the first region, and lead electrodes. The patient treatment system further comprises computer-readable media having instructions that cause the patient treatment system to perform operations comprising: (i) obtaining a physiological parameter of the patient, (ii) generating neuromodulation pulses based on the obtained physiological parameter, and (iii) delivering the neuromodulation pulses to the CSN afferent fibers via one or more of the lead electrodes. The physiological parameter can include at least one of blood pressure, heart rate, bioimpedance, or activity level of the patient.

Abstract: A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Abstract: A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Abstract: A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Abstract: Certain cardiac arrhythmias can be prevented by appropriate electrical stimulation of autonomic nerves innervating the heart. An implantable cardiac rhythm management device is configured to deliver such stimulation when an autonomic imbalance is predicted to be present via an endovascular electrode. Autonomic imbalance may be predicted to be present based upon circadian rhythms, detected heart rates, or detected heart rate variability.

Abstract: A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Abstract: A system and method for determining patient-specific implantable medical device programming parameters are presented. A set of physiological measures collected through a plurality of sensors monitoring physiological functions in a patient are assimilated. The physiological measures set are analyzed to identify physiological idiosyncrasies specific to the patient and to optimize the therapy to be delivered through an implantable medical device. A patient profile is formed including a plurality of programming parameters and the patient profile is preprogrammed into the implantable medical device prior to implantation in the patient.

Abstract: An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: Systems and methods provide for sensing of cardiac activity from a subcutaneous, non-intrathoracic location, and detecting a cardiac condition necessitating treatment in response to the sensed cardiac activity. One of a number of cardiac therapies may be selectively delivered to treat the detected cardiac condition, such cardiac therapies including at least a tachycardia therapy, a bradycardia therapy, and an asystole prevention therapy.

Abstract: An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: Subcutaneous leads that incorporate active fixation elements including, for example, helical coils, provide for fixation of cardiac lead components within a patient. An implantable lead includes a lead body with a supported electrode configured for subcutaneous non-intrathoracic placement within a patient. A fixation element is provided on the implantable lead and configured to actively secure one or both of the subcutaneous electrode and the lead body in tissue. A delivery apparatus comprising a sheath may be employed that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location. Lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead supporting an electrode, advancing the lead through the sheath, actively fixing the lead to tissue, and thereafter removing the sheath from the patient.

Abstract: Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.

Abstract: A method and apparatus for stimulation of a baroreflex system of a patient is provided. A method comprises establishing a therapy regimen including at least one pulse which includes at least two phases. Each phase has a polarity which is different than that of the other phase. The baroreflex system of the patient is activated with at least one baroreflex activation device which is responsive to the therapy regimen.

Abstract: Transthoracic cardiac stimulation therapies provide for detection and treatment of cardiac asystole subsequent to delivery of a defibrillation therapy. A pacing therapy is transthoracicly delivered to terminate detected cardiac asystole using residual energy from a defibrillation energy storage source. The residual energy usable for the pacing therapy is sufficient to transthoracicly deliver at least one pacing pulse, and is typically sufficient to deliver a series of pacing pulses, prior to depletion of the defibrillation energy storage source. Detection of cardiac asystole is performed following delivery of each pacing pulse, and subcutaneous pacing support is terminated in response to detecting cardiac asystole termination.

Abstract: Methods and devices of cardiac electrode placement involve locating electrodes on a thorax of a patient. Surface pacing levels are determined relative to a pacing limit. Surface electrode locations are selected or rejected based on the level being within a limit. Electrodes may be relocated to new locations, and new surface pacing levels determined, until a new surface pacing level falls within the pacing limit. Selecting or rejecting electrode locations involves selecting locations suitable for implantation of subcutaneous cardiac electrodes and implanting at the selected locations.

Abstract: Subcutaneous systems and leads may be fixed in tissue after placement by use of one or more expanding fixation elements. An expanding fixation element is provided on an implantable lead and configured to secure one or both of a subcutaneous electrode and the lead body within subcutaneous non-intrathoracic tissue. A delivery apparatus comprising a sheath may be included that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient. A method of lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead comprising a lead body and an electrode, and advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location. The method further involves fixing the lead to subcutaneous non-intrathoracic tissue using an expanding fixation element and thereafter removing the sheath from the patient.

Abstract: A cardiac rhythm management (CRM) system includes a programming device that determines parameters for programming an implantable medical device based on patient-specific information including indications for use of the implantable medical device. By executing an indication-based programming algorithm, the programming device substantially automates the process between the diagnosis of a patient and the programming of an implantable medical device using parameters individually determined for that patient.

Abstract: Systems, devices and methods are provided for providing sensing and therapy functions using a chronically-implanted device. According to one embodiment, the device includes a structure adapted to be chronically placed within a biosystem, and further includes sensing circuitry and therapy-providing circuitry attached to the structure. The sensing circuitry is adapted to sense mechanical parameters in the biosystem. The therapy-providing circuitry is adapted to provide therapy to the biosystem. According to various embodiments of the device, the sensing circuitry is further adapted to sense electrical and/or chemical parameters in the biosystem, and/or is adapted to provide electrical therapy and/or to provide drug-eluting therapy. One embodiment of the device includes a stent-like structure adapted to be chronically placed intravascularly in the biosystem.

Abstract: A method and apparatus for assessing the risk of atrial fibrillation in a patient by calculating the relative frequency of short and long intervals between successive heart beats during sinus rhythm is presented. An imbalance of short over long sinus intervals has been found to indicate a higher risk of atrial fibrillation. An implantable cardiac device may be configured to automatically deliver interventional therapy to restore sinus interval balance when such an imbalance is detected.

Abstract: Certain cardiac arrhythmias can be prevented by appropriate electrical stimulation of autonomic nerves innervating the heart. An implantable cardiac rhythm management device is configured to deliver such stimulation when an autonomic imbalance is predicted to be present via an endovascular electrode. Autonomic imbalance may be predicted to be present based upon circadian rhythms, detected heart rates, or detected heart rate variability.