Device Dossier

Micra single chamber transcatheter pacing system - Intracardiac pacemaker

Device Dossier for Micra single chamber transcatheter pacing system - Intracardiac pacemaker (Intracardiac pacemaker, Class III, sponsor Medtronic). ARTG…

Intended purpose

Indicated for use in patients who have experienced one or more of the following conditions: - symptomatic paroxysmal or permanent high-grade AV block in the presence of AF - symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy - symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy. Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.

Functional description

MR Conditional single chamber implantable transcatheter pacing system with SureScan technology is a programmable cardiac device that monitors and regulates the patient’s heart rate by providing rate-responsive bradycardia pacing to the right ventricle. The device senses the electrical activity of the patient’s heart, using the sensing and pacing electrodes enclosed in the titanium capsule of the device.

TGA Public Summary