Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Microport Crm Pty Ltd - Platinium 4LV SonR CRT-D 1844 - Biventricular pacemaker/defibrillator
ARTG entry for
Medical Device Included AIMD
Microport Crm Pty Ltd
44 Lakeview Drive,Scoresby, VIC, 3179
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.
MicroPort CRM S.r.l
Via Crescentino sn
Saluggia, VC, 13040
1. Platinium 4LV SonR CRT-D 1844 - Biventricular pacemaker/defibrillator
Single Device Product
47270 Biventricular pacemaker/defibrillator
Platinium SonR CRT-D 1844 implantable CRT-D for the recognition and treatment of ventricular
tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible
tachyarrhythmias. It has an accelerometer for adaption of pacing to suit patients activity and RF wireless
technology which enables remote monitoring of patients who have the Smartview monitor & wireless
interrogation & device programming by Orchestra Plus link
PLATINIUM 4LV SonR CRT-D 1844 is an implantable CRT-D indicated in:
? Patients who are survivors of cardiac arrest due to ventricular fibrillation or
hemodynamically unstable sustained VT after evaluation to define the cause of the event
and to exclude any completely reversible causes.
? Patients with structural heart disease and spontaneous sustained VT, whether
hemodynamically stable or unstable.
? Patients with syncope of undetermined origin with clinically relevant, hemodynamically
significant sustained VT or ventricular fibrillation induced at electrophysiological study.
? Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days
post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
? Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic
? Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and
inducible ventricular fibrillation or sustained VT at electrophysiological study.
Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite
optimal pharmacological therapy, with reduced LVEF and wide QRS.
Nil variant (as 1 device) Nil
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