Single-chamber pacemaker - Vietnam Registration 2400975ĐKLH/BYT-HTTB

Amvia Sky is a pacemaker implantable cardioverter defibrillator (PM: SR-T and DR-T) and a re-synchronization pacemaker (CRT-P: HF-T and HF-T QP). The pacemaker is a component of the implantable cardioverter defibrillator system, which includes the pacemaker and the signal wire. The primary function of the system is first to sense the intrinsic heart rhythm and second to provide pacing by low-energy electrical impulses, as well as to provide anti-tachycardia pacing by low-energy electrical impulses when necessary to ensure a stable heart rhythm or to support the intrinsic heart rhythm when necessary. The CRT-P systems have all the functions mentioned and in addition provide permanent sensing and pacing of the left ventricle. Implantation of a pacemaker is a symptomatic treatment with the following objectives: •Sensing and recording the heart rhythm and automatically detecting slow and fast heartbeats (PMs and CRT-Ps) •Compensating for slow heartbeats by pacing the heart or the ventricles or by sequential pacing of the atria and ventricles (AV) (PM and CRT-P) •Physiological pacing (LBB(A)P) by stimulating the conduction system (PM and CRT-P) •Terminating fast heartbeats (AT/AF) by anti-tachycardia pacing (ATP) in the atrium (PMs and CRT-Ps) •Re-synchronizing the heart by multi-site ventricular pacing or by physiological pacing (CRT-Ps, e.g., biventricular pacing)