Abstract: An implantable medical device has a housing having a proximal end, a distal end and an outer sidewall extending from the proximal end to the distal end. A fixation sheath includes a housing sheath portion extending along the outer sidewall of the housing, and a fixation member portion extending from the housing sheath portion. The housing sheath portion is advanceable from a first position along the outer sidewall of the housing in which the fixation member portion is retracted toward the proximal end of the housing to a second position along the outer sidewall of the housing in which the fixation member portion is deployed to extend away from the housing distal end for anchoring the implantable medical device at an implant site.

Abstract: A lead-in-lead system may include a first implantable lead having a first electrode and a second implantable lead having a second electrode guided by the first implantable lead to an implantation site. The second electrode may be implanted in a patient's heart distal to the first electrode at the same implantation site or at a second implantation site. Various methods may be used to deliver the lead-in-lead system to one or more implantation sites including at the triangle of Koch for ventricle-from-atrium (VfA) therapy, at the right ventricular septal wall for dual bundle-branch pacing, or in the coronary vasculature for left side sensing and pacing.

Abstract: A lead-in-lead system may include a first implantable lead having a first electrode and a second implantable lead having a second electrode guided by the first implantable lead to an implantation site. The second electrode may be implanted in a patient's heart distal to the first electrode at the same implantation site or at a second implantation site. Various methods may be used to deliver the lead-in-lead system to one or more implantation sites including at the triangle of Koch for ventricle-from-atrium (VfA) therapy, at the right ventricular septal wall for dual bundle-branch pacing, or in the coronary vasculature for left side sensing and pacing.

Abstract: A reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof. Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.

Abstract: VfA cardiac therapy uses an implantable medical device or system. The implantable medical device includes a tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body. The device may include a right atrial electrode, a right atrial motion detector, or both. The device may be implanted completely within the patient's heart or may use one or more leads to implant electrodes in the patient's heart. The device may be used to provide cardiac therapy, including single or multiple chamber pacing, atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. A separate medical device may be used to provide some functionality for cardiac therapy, such as sensing, pacing, or shock therapy.

Abstract: A method of delivering a pacing lead may include locating a potential implantation site adjacent to or within the triangle of Koch region of a patient's heart. The method may include advancing a pacing lead to the potential implantation site. The pacing lead has an elongate body and a fixation element coupled to a distal portion and attachable to the right-atrial endocardium adjacent to or within the triangle of Koch region. The method may include implanting the pacing lead at the potential implantation site to or sense electrical activity of the left ventricle in the basal and/or septal region of the left ventricular myocardium of the patient's heart. The pacing lead may include a lumen configured to receive a guide wire. A sheath of a delivery system used to deliver the pacing lead may include two or more curves to facilitate implanting the pacing lead at the implantation site.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: VfA cardiac therapy uses an implantable medical device or system. The implantable medical device includes a tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body. The device may include a right atrial electrode, a right atrial motion detector, or both. The device may be implanted completely within the patient's heart or may use one or more leads to implant electrodes in the patient's heart. The device may be used to provide cardiac therapy, including single or multiple chamber pacing, atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. A separate medical device may be used to provide some functionality for cardiac therapy, such as sensing, pacing, or shock therapy.

Abstract: VfA cardiac therapy uses an implantable medical device or system. The implantable medical device includes a tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body. The device may include a right atrial electrode, a right atrial motion detector, or both. The device may be implanted completely within the patient's heart or may use one or more leads to implant electrodes in the patient's heart. The device may be used to provide cardiac therapy, including single or multiple chamber pacing, atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. A separate medical device may be used to provide some functionality for cardiac therapy, such as sensing, pacing, or shock therapy.

Abstract: Cardiac electrical heterogeneity information may be used to determine whether one or more ventricle from atrium (VfA) paced settings for VfA pacing therapy are acceptable. Cardiac electrical heterogeneity information may be generated during VfA pacing, and then evaluated to determine whether the VfA paced settings are acceptable.

Abstract: VfA cardiac therapy uses an implantable medical device or system. The implantable medical device includes a tissue-piercing electrode implanted in the basal and/or septal region of the left ventricular myocardium of the patient's heart from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body. The device may include a right atrial electrode, a right atrial motion detector, or both. The device may be implanted completely within the patient's heart or may use one or more leads to implant electrodes in the patient's heart. The device may be used to provide cardiac therapy, including single or multiple chamber pacing, atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy. A separate medical device may be used to provide some functionality for cardiac therapy, such as sensing, pacing, or shock therapy.

Abstract: A system and method of positioning an atrial pacing lead for delivery of a cardiac pacing therapy that includes sensing electrical activity of tissue of a patient from a plurality of external electrodes and determining a distribution of bi-atrial activation in response to the sensed electrical activity. A target site for delivering the atrial pacing therapy is adjusted based on a change in bi-atrial dyssynchrony that is determined in response to the determined distribution of bi-atrial activation, and placement of the atrial pacing lead for delivery of the atrial pacing therapy is determined in response to the adjusting.

Abstract: A method, system and device for implanting an electrode assembly of an implantable medical device in a patient's heart. Positioning one or more radiopaque markers in a coronary sinus of the patient's heart. Positioning, by using the one or more positioned radiopaque markers as a fluoroscopic visual reference, a distal tip of a delivery catheter within a right atrium of the patient's heart so that a distal opening of a lumen of the catheter is against a septal wall of the heart at a location between the ostium of the coronary sinus and the A-V nodal area of the right atrium, and so that the tip of the catheter is generally directed toward a left ventricle of the patient's heart. Advancing the electrode assembly through the lumen of the catheter and into the septal wall.

Abstract: A catheter assembly includes a cap and a spring-biased tethering member coupled thereto. The cap includes first and second portions, and a transition zone extending therebetween. A girth of the first portion is sized to fit within a distal-most opening of the catheter assembly; and a girth of the second portion tapers from a first size at the transition zone, which is too large to fit within the distal-most opening, to a smaller size at a distal end of the cap. The spring-biased tethering member holds the cap in open and closed positions, when the cap first portion extends within the distal-most opening, and when the cap is separated from the distal-most opening, respectively. At the closed position, the first portion is approximately concentric with the distal-most opening, and at the open position, an entirety of the cap is laterally offset from the distal-most opening.

Abstract: Devices, systems, and methods for treating pulmonary conditions, such as COPD and asthma, by denervating bronchial tissue using cryoablation. In one embodiment, a device for bronchial denervation comprises: an elongate body having a distal portion and a proximal portion opposite the distal portion; a treatment element at the distal portion of the elongate body; and a first recording electrode located distal to the treatment element and a second recording electrode located proximal to the treatment element, the first and second recording electrodes being configured to record electromyograms. In one embodiment, the device includes a fluid delivery element that is within the treatment element and that has a plurality of orifices aligned with an equatorial portion of the treatment element.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: An implantable medical lead having an elongated lead body extending from a proximal end to a distal end, at least one conductor extending within the lead body from the proximal end to the distal end, and a fixation member having a proximal end and a distal end, the proximal end of the electrode configured to be electrically coupled to the distal end of the lead body.

Abstract: Cardiac electrical heterogeneity information may be used to determine whether one or more His bundle paced settings for His bundle pacing therapy are acceptable for His bundle pacing. Cardiac electrical heterogeneity information may be generated during His bundle pacing, and the evaluation against baseline information and/or other information to determine whether the His bundle paced settings are acceptable.

Abstract: An IMD system receives a near field His bundle electrical signal produced by a patient's heart via a first sensing electrode vector and a far field cardiac electrical signal via a second sensing electrode vector different than the first sensing electrode vector. The IMD system generates His bundle pacing pulses delivered to the patient's heart via a His pacing electrode vector and determines a type of cardiac capture evoked by a His bundle pacing pulse.

Abstract: An implantable medical device has a housing having a proximal end, a distal end and an outer sidewall extending from the proximal end to the distal end. A fixation sheath includes a housing sheath portion extending along the outer sidewall of the housing, and a fixation member portion extending from the housing sheath portion. The housing sheath portion is advanceable from a first position along the outer sidewall of the housing in which the fixation member portion is retracted toward the proximal end of the housing to a second position along the outer sidewall of the housing in which the fixation member portion is deployed to extend away from the housing distal end for anchoring the implantable medical device at an implant site.