Rivacor Sky HF-T - Biventricular pacemaker/defibrillator

Intended purpose

Rivacor Sky HF-T 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 • Physiological pacing of the left ventricle by stimulating the conduction system (LBBAP)

Functional description

Triple-chamber CRT-D with Home Monitoring functions. 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