Amvia Sky HF-T QP - Biventricular pacemaker

Intended purpose

Amvia Sky are implantable pacemakers (PM: SR-T and DR-T) and implantable cardiac resynchronization pacemakers (CRT-P: HF-T and HF-T QP). A pacemaker is part of an implantable pacemaker system comprising a pacemaker and leads. The primary function of the system is the ability, first, to sense the intrinsic heart rhythm/rate and, second, to provide pacing by electrical pulses of low energy, as well as to provide antitachycardia pacing by electrical pulses of low energy when necessary to ensure a stable heart rate or to support the intrinsic heart rate when needed. CRT-P systems share all mentioned functions and in addition provide permanent sensing and pacing of the left ventricle. The implantation of a pacemaker is a symptomatic therapy with the following objectives: • Sensing and recording the heart rhythm and automatically detecting bradycardia and atrial tachyarrhythmia (PMs and CRT-Ps). • Compensation of bradycardia through atrial or ventricular, or AV sequential pacing (PMs and CRT-Ps). • Physiological pacing (LBB(A)P) by stimulating the conduction system (PMs and CRT-Ps). • Termination of atrial tachycardia (AT/AF) through antitachycardia pacing (ATP) in the atrium (PMs and CRT-Ps). • Cardiac resynchronization through multisite ventricular pacing or through physiological pacing (CRT-Ps, e.g. biventricular pacing).

Functional description

Implantable triple-chamber cardiac resynchronization pacemaker that monitors the heart rhythm and automatically detects and treats bradycardia by providing electrical pulses to the heart. The device's housing is made of biocompatible titanium and serves as an antipole in the case of unipolar lead configuration. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. - Lead connector: IS-1/IS4 - Configuration: unipolar, bipolar