Device Dossier

Ellipse DR CD2377-36QC - Defibrillator, implantable, automatic

Device Dossier for Ellipse DR CD2377-36QC - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, AIMD, sponsor Abbott Medical).…

Intended purpose

The Ellipse DR CD2377-36QC is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF. This device is MRI conditional.

Functional description

The Ellipse DR CD2377-36QC is a dual chamber implantable cardioverter defibrillator (ICD) with RF telemetry and it monitors and regulates a patient's heart rate by providing ventricular tachyarrhythmia therapy. It features a DF4 device header and Parylene coating.

TGA Public Summary