AUTOGEN CRT-D Model G172 - Defibrillator, implantable, automatic

Intended purpose

Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: · Moderate to severe heart failure (NYHA Class III-IV) with EF less than or equal to 35% and QRS duration greater than or equal to 120 ms · Left bundle branch block (LBBB) with QRS duration greater than or equal to 130 ms, EF less than or equal to 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure Boston Scientific CRT-Ds are also intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Functional description

CRT-Ds provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias through a range of low- and high-energy shocks using a biphasic waveform and choice of multiple shock vectors.