Device Dossier

Acticor Sky HF-T QP - Biventricular pacemaker/defibrillator

Device Dossier for Acticor Sky HF-T QP - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor Biotronik).…

Intended purpose

Acticor Sky HF-T QP are cardiac resynchronization therapy defibrillators (CRT-Ds). An CRT-D is part of an implantable system comprising an implantable CRT-D along with pacing and ICD leads. The implantation of a CRT-D device is performed for the following objectives: • Monitoring the intrinsic heart rhythm and rate and detecting ventricular arrhythmias • Termination of ventricular tachycardia (VT) through antitachycardia pacing (ATP) • Termination of atrial tachycardia (AT/AF) through antitachycardia pacing (ATP) • Termination of ventricular fibrillation (VF) or ventricular tachycardia (VT) through shock delivery • Correction of bradycardia through atrial, ventricular or AV sequential pacing • Cardiac resynchronization through biventricular or left ventricular pacing

Functional description

Triple-chamber CRT-D with Home Monitoring functions and IS4 port. The device's ellipsoid shape facilitates implantation in the pectoral muscle area. The device detects tachyarrhythmias and restores physiological heart rate and rhythm. It also detects bradycardia and establishes physiological heart rate. CRT-Ds provide the additional benefit of improving the ejection fraction and/or cardiac output in patients with heart failure and intraventricular dyssynchrony. MR conditional

TGA Public Summary