Abstract: A biostimulator, such as a leadless pacemaker, having electrode(s) coated with low-polarization coating(s), is described. A low-polarization coating including titanium nitride can be disposed on an anode, and a low-polarization coating including a first layer of titanium nitride and a second layer of platinum black can be disposed on a cathode. The anode can be an attachment feature used to transmit torque to the biostimulator. The cathode can be a fixation element used to affix the biostimulator to a target tissue. The low-polarization coating(s) impart low-polarization to the electrode(s) to enable an atrial evoked response to be detected and used to effect automatic output regulation of the biostimulator. Other embodiments are also described and claimed.

Abstract: A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curvate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.

Abstract: Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

Abstract: Disclosed herein is a catheter for delivering an implantable medical lead to an implantation site near an ostium leading to a proximal region of a coronary sinus. The catheter includes a distal end, a proximal end opposite the distal end, a tubular body extending between the distal and proximal ends, an atraumatic fixation structure defining a distal termination of the distal end, and a lead receiving lumen. The atraumatic fixation structure is configured to enter the ostium and passively pivotally anchor with the proximal region of the coronary sinus. The lead receiving lumen extends along the tubular body from the proximal end to an opening defined in a side of the tubular body near the distal end and proximal the atraumatic fixation structure.

Abstract: Implantable systems, and methods for use therewith, monitor a patient's arterial blood pressure without requiring an intravascular pressure transducer. A plurality of calibrations factors are stored, each of which is associated with a respective one of a plurality of different postures, activity levels, or HR ranges, or different combinations thereof. A signal indicative of activity of the patient's heart, and a signal indicative of changes in arterial blood volume of the patient are obtained, and a pulse arrival time (PAT) value is determined. A current posture, activity level, and/or HR of the patient is/are determined and used to identify stored calibration factor(s) that correspond thereto. Values indicative of the patient's arterial blood pressure is/are determined based on the PAT value and the stored calibration factor(s) identified based on the patient's current posture, activity level, and/or HR. Such value(s) and/or changes thereto can be used to trigger and/or adjust therapy.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: Described herein are implantable medical devices (IMDs), and methods for use therewith. In certain embodiments, a controller of an IMD controls when a pacing capacitor of the IMD is charged using a first voltage, when the pacing capacitor is being charged using a second voltage, and when the pacing capacitor is discharged to deliver a pacing pulse between anode and cathode electrodes of, or electrically coupled to, the IMD. By selectively charging the pacing capacitor for a portion of a charge duration using the second voltage, that is greater in magnitude than the first voltage that is used for delivering the pacing pulse, a magnitude of a polarization artifact superimposed on an evoked response within a cardiac electrical signal, sensed using a sensing circuit of the IMD, is reduced compared to if the pacing capacitor were instead charged using the first voltage for the entire charge duration.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: A computer implemented method for determining heart arrhythmias based on cardiac activity that includes under control of one or more processors of an implantable medical device (IMD) configured with specific executable instructions to obtain far field cardiac activity (CA) signals at electrodes located remote from the heart, and obtain acceleration signatures, at an accelerometer of the IMD, indicative of heart sounds generated during the cardiac beats. The IMD is also configured with specific executable instructions to declare a candidate arrhythmia based on a characteristic of at least one R-R interval from the cardiac beats, and evaluate the acceleration signatures for ventricular events (VEs) to re-assess a presence or absence of at least one R-wave from the cardiac beats and based thereon confirming or denying the candidate arrhythmia.

Abstract: The present disclosure provides systems and methods for applying anti-tachycardia pacing (ATP) using subcutaneous implantable cardioverter-defibrillators (SICDs). An SICD implantable in a subject includes a case including a controller, and at least one conductive lead extending from the case. The at least one conductive lead includes a plurality of coil electrodes, wherein the SICD is configured, via the controller, to apply anti-tachycardia pacing (ATP) to the subject using the at least one conductive lead.

Abstract: A subcutaneous implantable medical device and method (SIMD) provided. A pulse generator (PG) is configured to be positioned subcutaneously within a lateral region of a chest of a patient. The PG has a housing that includes a PG electrode. The PG has an electronics module. An elongated lead is electrically coupled to the pulse generator. The elongated lead includes a first electrode that is configured to be positioned along a first parasternal region proximate a sternum of the patient and a second electrode that is configured to be positioned at an anterior region of the patient. The first and second electrodes are coupled to be electrically common with one another. The electronics module is configured to provide electrical shocks for antiarrhythmic therapy along at least one shocking vector between the PG electrode and the first and second electrodes.

Abstract: Computer implemented methods and systems for detecting noise in cardiac activity are provided. The method and system obtain a far field cardiac activity (CA) data set that includes far field CA signals for a series of beats, overlay a segment of the CA signals with a noise search window, and identify turns in the segment of the CA signals. The method and system determine whether the turns exhibit a turn characteristic that exceed a turn characteristic threshold, declare the segment of the CA signals as a noise segment based on the determining operation, shift the noise search window to a next segment of the CA signal and repeat the identifying, determining and declaring operations; and modify the CA signals based on the declaring the noise segments.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: Computer implemented methods and systems for detecting noise in cardiac activity are provided. The method and system obtain a far field cardiac activity (CA) data set that includes far field CA signals for a series of beats, overlay a segment of the CA signals with a noise search window, and identify turns in the segment of the CA signals. The method and system determine whether the turns exhibit a turn characteristic that exceed a turn characteristic threshold, declare the segment of the CA signals as a noise segment based on the determining operation, shift the noise search window to a next segment of the CA signal and repeat the identifying, determining and declaring operations; and modify the CA signals based on the declaring the noise segments.

Abstract: Methods and implantable medical devices are provided that include a lead configured to be operably coupled to a pulse generator and subcutaneously implanted within a patient. The lead includes an electrode configured to receive electrical power from the pulse generator and to deliver high-voltage shocks for defibrillation therapy. The electrode has an oblong cross-sectional shape with a major dimension that is at least 10 French (F).

Abstract: Methods and systems are provided for detecting arrhythmias in cardiac activity. The methods and systems declare a current beat, from the CA signals, to be a candidate beat or an ineligible beat based on whether the current beat satisfies the rate based selection criteria. The determining and declaring operations are repeated for multiple beats to form an ensemble of candidate beats. The method and system calculate a P-wave segment ensemble from the ensemble of candidate beats, perform a morphology-based comparison between the P-wave segment ensemble and at least one of a monophasic or biphasic template, declare a valid P-wave to be present within the CA signals based on the morphology-based comparison, and utilize the valid P-wave in an arrhythmia detection process to determine at least one of an arrhythmia entry, arrhythmia presence or arrhythmia exit.

Abstract: Systems and methods for implanting a lead. The system includes an active guidewire having proximal and distal ends. The distal end includes a guidewire anchor that is configured to be attached to a target SOL. The active guidewire is configured to be utilized to electrically map the target SOI by at least one of delivering stimulation energy through the active guide wire to the target SOI or sensing an evoked response at the target SOI from the guidewire. The system also includes a lead having a lead body with proximal and distal ends and with a lumen extending between the proximal and distal ends. The distal end of the lead body is configured to receive the proximal end of the active guidewire. The lumen is configured to permit the lead body to be advanced over the active guidewire.