An open coiled pacemaker lead is provided that has improved structural stability and functional life in vivo. The open coiled lead includes an electrically conductive material that is coated or covered by a thin layer of electrically insulative material. The coated coiled lead has adequate spacing between adjacent coils, and has a lumen of sufficient diameter, to allow for infiltration of biological connective tissue onto the surface of the coated coil when maintained in vivo for a sufficient amount of time. Infiltration of the connective tissue essentially uniformly along the entire coiled lead strengthens and lengthens the functional life of the coated coil lead.

The invention relates to a heart valve regurgitation drum and optional closure disk and/or tubular stent to manage and provide levels of intentional regurgitation within an orthogonally delivered transcatheter prosthetic heart valve having a first inner flow control component/valve, a second inner regurgitation control component, and an outer annular support frame having compressible wire cells that facilitate folding flat along the z-axis and compressing the valve vertically along the y-axis, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.

Methods, devices and program products are provided for under control of one or more processors within an implantable medical device (IMD). Sensing near field (NF) and far field (FF) signals are between first and second combinations of electrodes coupled to the IMD. The method applies an arrhythmia detection algorithm to the NF signals for identifying events within the NF signal and designates events marker based thereon and monitors the event markers to detect a candidate arrhythmia condition in the NF signals. The candidate under-detected condition comprises at least one of an under-detected arrhythmia or over-sensing. In response to detection of the candidate arrhythmia condition, the method analyzes the FF signals for a presence of an under-detected arrhythmia indicator. The method delivers an arrhythmia therapy based on the presence of the under-detected arrhythmia indicator in the FF signals and the candidate under-detected arrhythmia condition in the NF signals.

Described is a low voltage, pulsed electrical stimulation device (bioelectric stimulator associated with electrodes) for controlling expression of S100 protein(s) by cellular tissues. The bioelectric stimulator is useful in methods to treat a subject suffering from bladder, heart, and/or nerve tissue damage.

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include a proximal section including a deflection mechanism for deflecting the proximal section, and a distal holding section extending distally of a distal end of the proximal section and defining a cavity therein for receiving an implantable leadless pacing device. The distal holding section may be structured to have portions that flex and bend while allowing the implantable device to be recaptured within the distal holding section.

Systems and methods for rate-adaptive pacing are disclosed. In one illustrative embodiment, a medical device for delivering electrical stimulation to a heart may include a housing configured to be implanted on the heart or within a chamber of the heart, one or more electrodes connected to the housing, and a controller disposed within the housing. The controller may be configured to sense a first signal and determine a respiration rate based at least in part on the sensed first signal. In at least some embodiments, the controller may be further configured to adjust a rate of delivery of electrical stimulation by the medical device based at least in part on the determined respiration rate.

A medical system comprising a guiding catheter having an inflation lumen. The inflation lumen extends within a handle and a shaft of the guiding catheter. An inflatable sleeve has a proximal end and a distal end, with the ends attached to the guiding catheter. A sealed interior portion of the inflatable sleeve is bounded by the inflatable sleeve and the shaft of the guiding catheter, and in fluid communication with a distal port of the inflation lumen. The system further comprises a delivery catheter defining a delivery lumen and configured for sliding engagement within the guide lumen of the guiding catheter.

Ventricle-from-atrium (VfA) cardiac therapy may utilize a tissue-piercing electrode implanted in the left ventricular myocardium of the patient's heart from the right atrium through the right atrial endocardium and central fibrous body. The exemplary devices and methods may determine whether the tissue-piercing electrode is achieving effective left ventricular capture. Additionally, one or more pacing parameters, or paced settings, may be adjusted in view of the effective left ventricular capture determination.

A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.

A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.