AUTOGEN CRT-D Model G179 - Defibrillator, implantable, automatic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Boston Scientific Pty Ltd

Class:

AIMD

Manufactured by:

Boston Scientific Corporation 4100 Hamline Avenue North, Saint Paul, MN, 55112 United States Of America

Therapeutic area:

35852 - Defibrillator, implantable, automatic

Therapeutic indications:

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.

Authorization status:

Included

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