A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.

Various embodiments of a sealed package and a method of forming such package are disclosed. The package can include a non-conductive substrate that includes a cavity disposed in a first major surface. A cover layer can be disposed over the cavity and attached to the first major surface of the non-conductive substrate to form a sealed enclosure. The sealed package can also include a feedthrough that includes a via between a recessed surface of the cavity and a second major surface of the substrate, and a conductive material disposed in the via. An external contact can be disposed over the via on the second major surface of the non-conductive substrate, where the external contact is electrically connected to the conductive material disposed in the via. The sealed package can also include an electronic device disposed within the sealed enclosure that is electrically connected to the external contact.

An implantable medical product and method of use for substantially reducing or eliminating harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in in a body of a warm blooded mammal. The bioremodelable pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either: (a) first and second sheets, or (b) a single sheet having first and second sheet portions. After receiving the electrical device, the edges around the opening are closed by suturing or stapling. The medical device encased by the bioremodelable pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in the body of the mammal.

A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.

A biostimulator and a pace mapping system for deep septal pacing. The biostimulator includes a pacing element that extends distally beyond a fixation element. The pacing element is insulated between a distal tip of the fixation element and a distal portion of the pacing element. The pace mapping system can be used to determine a distance between a septal wall of a heart septum and a bundle branch within the septum. The pacing element can be selected based on the distance, and delivered into the septum to pace the bundle branch. Other embodiments are also described and claimed.

An electronic assembly, including an encasement joined from at least two casing parts, wherein at least one gap region between two mutually adjoining casing parts is hermetically sealed by a metal layer that is electrodeposited onto the sections of the adjoining casing parts abutting the gap region and bridges the gap region.

Various embodiments of an implantable medical device and a method of forming such device are disclosed. The device includes a housing that has a first portion and a second portion connected to the first portion. The first portion includes a polymer material and the second portion includes a transparent polymer material. The housing further includes a lead bore that extends between a first end at an outer surface of the housing and a second end disposed within the housing.

Various embodiments of an implantable medical device and a system that includes such device are disclosed. The device includes a housing including a polymeric material, and an electronics module disposed within the housing and having a substrate, a power source disposed on the substrate, and circuitry disposed on the substrate and electrically connected to the power source. The device also includes a conformal coating disposed over at least a portion of the electronics module.

In some examples, processing circuitry of a medical device system determines, for each of a plurality of patient parameters, a difference metric for a current period based on a value of a patient parameter determined for the current period and a value of the patient parameter determined for an immediately preceding period, and determines a score for the current period based on a sum of the difference metrics for at least some of the plurality of patient parameters. The processing circuitry determines a threshold for the current period based on scores determined for N periods that precede the current period, compares the score for the current period to the threshold, and determines whether to generate an alert indicating that an acute cardiac event of the patient, e.g., ventricular tachyarrhythmia, is predicted, and/or deliver a therapy configured to prevent the acute cardiac event, based on the comparison.

An enclosure for an implantable cardiac or neurostimulation device includes a bulk metallic glass alloy. In some arrangements, the enclosure is configured to house one or more components of an implantable pacemaker. In some arrangements, the enclosure is configured to house one or more components of an implantable defibrillator.