Device Dossier

MOMENTUM X4 CRT-D Model G138 - Biventricular pacemaker/defibrillator

Device Dossier for MOMENTUM X4 CRT-D Model G138 - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor Boston…

Intended purpose

Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacological 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 ≤ 35% and QRS duration ≥ 120 ms - Left bundle branch block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure Boston Scientific implantable cardioverter defibrillators (CRT-Ds) are also intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

Functional description

MOMENTUM X4 CRT-D provides ventricular tachyarrhythmia therapy, cardiac resynchronization therapy and bradycardia pacing through a range of low- and high-energy shocks using a biphasic waveform. It has a choice of multiple shock vectors and can provide multi-site pacing.

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