Device Dossier
Ellipse VR CD1377-36C - Defibrillator, implantable, automatic
Device Dossier for Ellipse VR CD1377-36C - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, AIMD, sponsor Abbott Medical).…
- GMDN category: Defibrillator, implantable, automatic
Intended purpose
The Ellipse VR CD1377-36C 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.
Functional description
The Ellipse VR CD1377-36C is a single 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 an IS-1/DF-1 device header and Parylene coating.