Device Category Dossier

Biventricular pacemaker/defibrillator

Device Category Dossier for Biventricular pacemaker/defibrillator. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Implantable cardiac resynchronisation therapy defibrillators (CRT-Ds) are part of an implantable system comprising an implantable CRT-D along with pacing and ICD leads that monitor heart rhythm, detect arrhythmias, and deliver pacing or shock therapy to terminate abnormal rhythms and resynchronise ventricular contractions. These devices are used to manage patients with ventricular and atrial arrhythmias, bradycardia, and heart failure by detecting ventricular arrhythmias, terminating ventricular tachycardia and fibrillation through antitachycardia pacing or shock delivery, correcting bradycardia through sequential pacing, and achieving cardiac resynchronisation through biventricular or left ventricular pacing.