Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Intica 7 HF-T - 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. Intica 7 HF-T - Biventricular pacemaker/defibrillator
Single Device Product
47270 Biventricular pacemaker/defibrillator
This is a triple chamber, rate adaptive ICD with home monitoring functions. Max shock energy 40J,
IS-1/DF-1 connector. The housing is biocompatible titanium and hermetically sealed. The ellipsoid shape
facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing and shock
delivery are found in the device header. The housing serves as a potential antipole during shock delivery
or in the case of unipolar lead configuration. MRI compatibility is
Intica 7 HF-T belongs to a family of implantable cardioverter-defibrillators(ICD). 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 hemodynamically 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) 404627
No Specific Conditions included on Record
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