Abstract: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached, includes a shaft assembly including a distal end and a coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve. The system includes a sheath assembly defining a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The coupling structure is configured to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly.

Abstract: Implantable medical lead devices such as leads and lead extensions include conductors within the lead device body that interconnect proximal and distal electrical connectors and that have balanced clocked positions. The balanced clocked positions may be achieved by separating a first conductor from a second conductor by an adequate amount, where the first conductor has a length as measured from a given point along the lead to the end of the conductor that is most similar to the length of the second conductor as measured in the same manner. The balanced clocked position of conductor pairings based on similarity of length may provide benefits such as reducing the tendency of the lead to curve when one or more layers of the lead body are being injection molded around the conductors.

Abstract: An occlusion device for the left atrial appendage is plastically deformable and biodegradable.

Abstract: Devices and implantation methods utilizing subcutaneous placement into a patient are disclosed for the insertion, advancement and positioning of a subcutaneous implantable medical device (SIMD) such as a medical electrical lead. The device for implanting the SIMD is configured having a pre-biased distal curve for creating a pathway to an implant location within a substernal space.

Abstract: Peripheral nerve field stimulation (PNFS) may be controlled based on detected physiological effects of the PNFS, which may be an efferent response to the PNFS. In some examples, a closed-loop therapy system may include a sensing module that senses a physiological parameter of the patient, which may be indicative of the patient's response to the PNFS. Based on a signal generated by the sensing module, the PNFS may be activated, deactivated or modified. Example physiological parameters of the patient include heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflex, or thermal activity of the patient's body. In some examples, a patient pain state may be detected based on a signal generated by the sensing module, and therapy may be controlled based on the detection of the pain state.

Abstract: A method comprises identifying P-waves within a cardiac signal stored by a medical device for a cardiac episode detected by the medical device, and calculating a gain factor for display of the cardiac signal based on the identified P-waves.

Abstract: A lead impedance stimulation architecture and a dual current source and sink methodology to output a biphasic current pulse and measure a resulting induced voltage across the stimulation electrodes to determine lead impedance. A common mode capacitance on the electrode interface may have little impact on the stimulation architecture of this disclosure allowing for fast voltage rise time and consistent and accurate impedance measurement. In addition, the dual source and sink includes a monitor circuit on each of the source and the sink circuitry. In the event of an open circuit indicating a lead breakage, loose connection, lead migration, insulation leak, and so on, the monitor circuit may provide an output to indicate specifically which electrode is unable to reach the correct current stimulation amplitude. In this manner the techniques of this disclosure, may also detect a lead break in a single lead impedance measurement.

Abstract: A system comprises a hand-held burr hole device insertion tool having a first end and a second end, the first end configured for simultaneous application of a normal force to two or more attachment points of a burr hole device component is disclosed.

Abstract: An implantable medical lead comprising one or more tines configured to extend and/or retract from a lead body. The implantable medical lead includes a torque member within the implantable medical lead and configured to rotate a drive shaft within the implantable medical lead. The drive shaft is threadably engaged with an interior surface of the implantable medical lead and configured to convert the rotation into a lateral translation of the drive shaft. The one or more tines are configured such that the lateral translation of the torque member laterally translates the one or more tines. The one or more tines are each electrically connected to a conductor extending through a lumen of the implantable medical lead and electrically isolated from each other.

Abstract: In some examples, a medical device delivery system includes a device cup configured to retain the medical device at the distal end of a catheter, the cup having a cylindrical body defining at least one vent hole extending from an exterior surface of the body to an interior surface of the body, and at least one internal rib extending inwardly from the interior surface, the rib configured to contact the medical device.

Abstract: A medical device includes a motion sensor configured to produce a motion signal and a control circuit configured to sense atrial events from the motion signal. In some examples, the control circuit is configured to set a ventricular diastolic event window and set a threshold amplitude during the ventricular diastolic event window for sensing an atrial event in response to the motion signal crossing the threshold amplitude during the ventricular diastolic window. The control circuit may determine a maximum amplitude of the motion signal during the ventricular diastolic event window for multiple ventricular cycles and determine an amplitude metric based on at least a portion of the determined maximum amplitudes. The control circuit may determine a target value of the threshold amplitude based on at least the amplitude metric and adjust the threshold amplitude toward the target value.

Abstract: A medical device is configured to detect an atrial tachyarrhythmia episode. The device senses a cardiac signal, identifies R-waves in the cardiac signal attendant ventricular depolarizations and determines classification factors from the R-waves identified over a predetermined time period. The device classifies the predetermined time period as one of unclassified, atrial tachyarrhythmia and non-atrial tachyarrhythmia by comparing the determined classification factors to classification criteria. A classification criterion is adjusted from a first classification criterion to a second classification criterion after at least one time period being classified as atrial tachyarrhythmia. An atrial tachyarrhythmia episode is detected by the device in response to at least one subsequent time period being classified as atrial tachyarrhythmia based on the adjusted classification criterion.

Abstract: A delivery system for percutaneously deploying a valve prosthesis. The system includes a catheter assembly including a delivery sheath capsule and a handle having an oscillating device. The capsule is configured to compressively retain the valve prosthesis during implantation. After the valve prosthesis is partially exposed during implantation, the oscillating device can create a vibratory motion to reduce the friction between the valve prosthesis and the delivery sheath capsule in order to recapture the valve prosthesis.

Abstract: Medical devices provide metallic connector enclosures. The metallic connector enclosures may be constructed with relatively thin walls in comparison to polymer connector enclosures to aid in miniaturizing the medical device. The metallic connector enclosures may be constructed with interior surfaces that deviate less from an ideal inner surface shape in comparison to polymer connector enclosures to allow for better concentricity of electrical connectors. The metallic connector enclosures may include a panel that allows access to the cavity of the connector enclosure where set screw blocks, lead connectors, spacers, seals, and the like may be located. Furthermore, the lead connectors within the metallic connector enclosures may be separated from the metallic connector enclosure by being positioned within non-conductive seals that reside within features included in cavity walls of the connector enclosure.

Abstract: A medical device includes a motion sensor configured to produce a motion signal and a control circuit configured to set sensing control parameters and sense atrial events from the motion signal during ventricular cycles according to the sensing control parameters. In some examples, the control circuit is configured to determine a feature of the motion signal for at least some ventricular cycles, determine a metric of the motion signal based on the determined features, and adjust at least one of the sensing control parameters based on the metric.

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: An apparatus for fastening around a cranial burr hole includes a substantially flat core and a shell encapsulating a ring portion of the core. The shell defines an orifice substantially centered within the ring portion, and has a contoured lower surface to match the cranial curvature. Pliable arms of the core extend laterally from the ring portion, each being terminated by a fastener member. A central portion of a placement tool for the apparatus has a lower part configured to extend through the apparatus orifice, and an upper part from which first and second arms of the tool extend laterally. Each tool arm is terminated with a receptacle to hold a bone screw, and, when the tool central portion lower part extends through the apparatus orifice, each receptacle aligns with a corresponding fastener member, and lower openings of the receptacles are generally oriented along the contoured lower surface.

Abstract: A medical device is configured to sense a cardiac signal that includes far field ventricular event signals and determine a ventricular activity metric from the sensed cardiac signal. The ventricular activity metric may be representative of a ventricular rate or an atrioventricular time interval. The medical device is configured to determine an atrioventricular synchrony metric based on the ventricular activity metric and generate an output based on the atrioventricular synchrony metric. The device may include a memory configured to store data corresponding to the atrioventricular synchrony metric.