Unify Assura CD3361-40C - Defibrillator, implantable, automatic

Intended purpose

The Unify Assura CD3361-40C is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. 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 Unify Assura CD3361-40C is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient’s heart rate by providing ventricular tachyarrhythmia therapy and Single Site Pacing. It features an IS-1/DF-1 device header and Parylene coating.