Device Dossier
MOMENTUM CRT-D Model G125 - Biventricular pacemaker/defibrillator
Device Dossier for MOMENTUM CRT-D Model G125 - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor Boston…
- GMDN category: Biventricular pacemaker/defibrillator
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 ≤ 35% and QRS duration ≥ 120 ms • Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 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
MOMENTUM 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; and a choice of multiple shock vectors.