AUTOGEN CRT-D Model G173 - Defibrillator, implantable, automatic

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
23-11-2017

제공처:

Boston Scientific Pty Ltd

수업:

AIMD

Manufactured by:

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

치료 영역:

35852 - Defibrillator, implantable, automatic

치료 징후:

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.

승인 상태:

Included

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