Abstract: A system and device are provided which include a gene regulatory system controlling expression of one or more expression cassettes present in or released by the device, by emitting one or more stimulations. An expression cassette includes a regulatable transcription control element that is responsive to the emitted stimulations linked to an open reading frame of interest. The system optionally includes a sensor to sense a parameter indicative of a need, a telemetry module to receive an external command, or a programmable device, for regulating gene expression of the open reading frame.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a pulse generator, a lead, a sensor, and a controller. The pulse generator generates a baroreflex stimulation signal as part of a baroreflex therapy. The lead is adapted to be electrically connected to the pulse generator and to be intravascularly fed into a heart. The lead includes an electrode to be positioned in or proximate to the heart to deliver the baroreflex signal to a baroreceptor region in or proximate to the heart. The sensor senses a physiological parameter regarding an efficacy of the baroreflex therapy and provides a signal indicative of the efficacy. The controller is connected to the pulse generator to control the baroreflex stimulation signal and to the sensor to receive the signal indicative of the efficacy of the baroreflex therapy. Other aspects are provided herein.

Abstract: The invention relates to systems, devices, and methods for detecting infections associated with implantable medical devices. In an embodiment, the invention includes a method of detecting infection in a patient including measuring a physiological parameter using a chronically implanted sensor at a plurality of time points and evaluating the physiological parameter measurements to determine if infection is indicated. In an embodiment, the invention includes an implantable medical device including a first chronically implantable sensor configured to generate a first signal corresponding to a physiological parameter and a controller disposed within a housing, the controller configured to evaluate the first physiological parameter signal to determine if an infection is indicated. Other embodiments are also included herein.

Abstract: A lead having a pre-formed biased portion is adapted for implantation with a body vessel and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are biased toward a vessel wall by the preformed biased portion, which operates to fixate the lead against the vessel wall.

Abstract: An implantable lead having a distal assembly including a coupler, a fixation helix secured to the coupler, a housing in which the fixation helix and the coupler are disposed, and a resilient seal that is fixedly secured to the coupler between proximal and distal ends thereof and able to translate with the coupler relative to the housing. The seal is positioned to sealingly engage an internal surface of the housing. When the coupler is translated such that the fixation helix is in a fully extended position, the seal is positioned to substantially seal off the housing to prevent tissue ingrowth.

Abstract: An apparatus includes a flexible lead body extending from a proximal end to a distal end, an expandable electrode coupled proximate the distal end, the expandable electrode having an expanded diameter dimensioned to abut a wall of a pulmonary artery, and an implantable pulse generator electrically coupled to the expandable electrode. The expandable electrode includes a plurality of electrode zones. The plurality of zones can be tested to determine which zone delivers the best baroreflex response. At least one of the electrode zones can be selected to deliver a stimulation signal based on the testing. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Abstract: An implantable system for ambulatory monitoring of a high-risk heart failure patient includes a first pressure sensor implantable within an abdomen of the patient for sensing and generating an output representative of a baseline intra-abdominal pressure value of the patient and for chronically sensing and generating an output representative of an intra-abdominal pressure value of the patient at periodic intervals. At least one second implantable sensor is provided for sensing and generating an output representative of a second physiological parameter of the patient. Additionally, the system includes a processor for correlating the output of the first pressure sensor and the second physiologic sensor, and for comparing differences between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values. The processor can reside in another implantable device or in an external device/system.

Abstract: Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a pulse generator, a lead, a sensor, and a controller. The pulse generator generates a baroreflex stimulation signal as part of a baroreflex therapy. The lead is adapted to be electrically connected to the pulse generator and to be intravascularly fed into a heart. The lead includes an electrode to be positioned in or proximate to the heart to deliver the baroreflex signal to a baroreceptor region in or proximate to the heart. The sensor senses a physiological parameter regarding an efficacy of the baroreflex therapy and provides a signal indicative of the efficacy. The controller is connected to the pulse generator to control the baroreflex stimulation signal and to the sensor to receive the signal indicative of the efficacy of the baroreflex therapy. Other aspects are provided herein.

Abstract: A lead having a pre-formed biased portion is adapted for implantation with a body vessel and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are biased toward a vessel wall by the preformed biased portion, which operates to fixate the lead against the vessel wall.

Abstract: A medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes an expandable distal portion having one or more spirals for securing and stabilizing the lead within the vessel.

Abstract: An implantable lead having a distal assembly including a coupler, a fixation helix secured to the coupler, a housing in which the fixation helix and the coupler are disposed, and a resilient seal that is fixedly secured to the coupler between proximal and distal ends thereof and able to translate with the coupler relative to the housing. The seal is positioned to sealingly engage an internal surface of the housing. When the coupler is translated such that the fixation helix is in a fully extended position, the seal is positioned to substantially seal off the housing to prevent tissue ingrowth.

Abstract: Various aspects of the present subject matter provide an implantable medical device. In various embodiments, the device comprises a pulse generator, a lead, a sensor, and a controller. The pulse generator generates a baroreflex stimulation signal as part of a baroreflex therapy. The lead is adapted to be electrically connected to the pulse generator and to be intravascularly fed into a heart. The lead includes an electrode to be positioned in or proximate to the heart to deliver the baroreflex signal to a baroreceptor region in or proximate to the heart. The sensor senses a physiological parameter regarding an efficacy of the baroreflex therapy and provides a signal indicative of the efficacy. The controller is connected to the pulse generator to control the baroreflex stimulation signal and to the sensor to receive the signal indicative of the efficacy of the baroreflex therapy. Other aspects are provided herein.

Abstract: A medical electrical lead comprises a flexible, elongate lead body extending along a longitudinal axis and having a proximal end and a distal end. A protective distal tip structure is disposed on the distal end of the lead body. The tip structure includes a plurality of compliant projections each extending distally from the distal end of the body in the direction of the longitudinal axis. The projections are configured to contact and bear against cardiac tissue when the lead is implanted, and are deformable under the action of an axially or radially directed force. The projections optionally include a coating over a substrate. The coating can include a hydrogel material and/or a pharmaceutical agent such as a steroid for reducing inflammation at the implantation site.

Abstract: An apparatus includes an implantable device, such as a chronically implantable device that has a device body. One or more chemical sensors are coupled with the device body. A drug eluting substance is disposed at a location including at least one of on, directly adjacent, or near the one or more chemical sensors, where the drug eluting substance prevents fibrotic growth on the one or more chemical sensors.

Abstract: A medical electrical lead includes a drug eluting coating provided over at least a portion of the lead body. The drug eluting coating can be provided over at least a portion of the lead body and adjacent to at least one electrode located on the lead body. The drug eluting coating can include at least one matrix polymer layer including a polymer admixed with a therapeutic agent. The therapeutic agent, for example, can be an anti-proliferative agent or an anti-inflammatory agent. The matrix polymer can include a medical adhesive. The rate of elution of the drug from the matrix polymer layer is affected by the drug to polymer ratio of the drug in the matrix polymer layer.

Abstract: An apparatus includes a flexible lead body extending from a proximal end to a distal end, the distal end having a biased portion having an outer diameter dimensioned to abut a wall of a pulmonary artery, an electrode coupled proximate the distal end, and an implantable pulse generator electrically coupled to the electrode. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Abstract: An apparatus includes a flexible lead body extending from a proximal end to a distal end, an expandable electrode coupled proximate the distal end, the expandable electrode having an expanded diameter dimensioned to abut a wall of a pulmonary artery, and an implantable pulse generator electrically coupled to the expandable electrode. The expandable electrode includes a plurality of electrode zones. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Abstract: An epicardial patch includes an extracellular matrix (ECM) and a plurality of electrodes. The isolated ECM is configured for epicardial attachment over a myocardial region including an injured area to control post-injury remodeling of the myocardial region. The plurality of electrodes is configured for delivering electrical stimulation to enhance the effect of the isolated ECM in remodeling control by altering workload and stress on the myocardial region.