Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Boston Scientific Pty Ltd
AIMD
Boston Scientific Corporation 4100 Hamline Avenue North, Saint Paul, MN, 55112 United States Of America
35852 - Defibrillator, implantable, automatic
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. 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.
Included