Serena CRT-P MRI SureScan W1TR05 - Biventricular pacemaker

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

公众评估报告 公众评估报告 (PAR)
01-12-2017

可用日期:

Medtronic Australasia Pty Ltd

类:

AIMD

厂商:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

治疗领域:

47263 - Biventricular pacemaker

疗效迹象:

The Medtronic Serena CRT-P MRI SureScan Model W1TR05 dual chamber implantable pulse generator with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. This device features Bluetooth wireless technology. The Serena CRT-P MRI SureScan system is indicated for any of the following types of heart failure patients: ? Patients with ventricular dyssynchrony ? Patients with reduced ejection fraction (EF), regardless of New York Heart Association (NYHA) class, who are indicated for ventricular pacing, and have high degree AV block ? Patients with reduced EF and all of the following characteristics: ? Have received a conventional pacemaker or an ICD ? Have subsequently developed worsening heart failure despite optimal medical therapy ? Have a high proportion of RV pacing

授权状态:

A

授权日期:

2017-07-21

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