Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Ilivia 7 HF-T QP - Biventricular pacemaker/defibrillator
ARTG entry for
Medical Device Included AIMD
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
ARTG Start Date
Medical Device AIMD
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Biotronik SE & Co KG
, Berlin, 12359
1. Ilivia 7 HF-T QP - Biventricular pacemaker/defibrillator
Single Device Product
47270 Biventricular pacemaker/defibrillator
An implantable ICD; triple chamber; IS4 port connecting a quadripolar LV lead, rate adaptive, Home
Monitoring, max shock of 40J, IS-1/IS4/DF4 connector (MR conditional). Biocompatible titanium housing is
hermetically sealed; ellipsoid shape helps implanting in the pectoral muscle. Connections for bipolar
pacing, sensing; unipolar connections; & shock delivery are in the header. The housing serves as a
potential antipole during shock delivery or in the case of unipolar lead configuration.
Ilivia 7 HF-T QP belongs to a family of implantable cardioverter-defibrillators (ICDs). The primary objective
of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of
treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing.
The implantation of an ICD is a symptomatic therapy with the following objectives: Termination of
spontaneous ventricular fibrillation (VF) through shock delivery; Termination of spontaneous ventricular
tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffective ATP or haemodynamically
not tolerated VT, with shock delivery; Cardiac resynchronization through multisite ventricular pacing;
Compensation of bradycardia through AV sequential pacing. Triple-chamber ICDs are indicated for
patients with the following risks: Sudden cardiac death caused by ventricular arrhythmias; Congestive
heart failure with ventricular asynchrony.
Model number (see guidance docs) 404621
No Specific Conditions included on Record
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