Device Dossier

Entrant HF CRT-D Model CDHFA300Q - Biventricular pacemaker/defibrillator

Device Dossier for Entrant HF CRT-D Model CDHFA300Q - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor…

Intended purpose

Intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing, and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle, and various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or the right atrium. CRT-D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles.

Functional description

The device is a cardiac resynchronisation therapy defibrillator (CRT-D) monitors and regulates a patient's heart rate and provides treatment of ventricular arrhythmias. As a CRT-D device, it also senses cardiac activity and provides pacing to resynchronize the right and left ventricles.

TGA Public Summary