Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

1374 - Insertion of subcutaneous electrode for the purpose of use with an implantable cardioverter defibrillator (ICD)

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Application Number1374
Application NameInsertion of subcutaneous electrode for the purpose of use with an implantable cardioverter defibrillator (ICD)
Description of Medical ServiceThe subcutaneous ICD comprises of an electrode and pulse generator. In contrast to traditional ICDs, this ICD is entirely subcutaneous. Accordingly, the system does not require an electrode to be placed either on (epicardially) or in (endocardially) the heart and no leads are passed through the venous system. The implant procedure for the subcutaneous ICD involves making a pocket for the pulse generator in the lateral thoracic region. Using a tunnelling tool, the electrode is then placed in a subcutaneous sinus along the sternum. Using anatomical landmarks only, there is no need for fluoroscopy or other medical imaging during the surgical implant procedure. The electrode is connected to the pulse generator and the system then monitors cardiac rhythms, delivers defibrillation and/or post-shock bradycardia pacing therapies as required, and records ventricular tachyarrhythmia events for subsequent clinician review.
Description of Medical ConditionThe subcutaneous ICD is intended to provide defibrillation therapy for the treatment of life threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
Consultation Protocol 7 February 2014 – 21 March 2014
PDF version Consultation Protocol (PDF 403 KB)
Word version Consultation Protocol (Word 943 KB)
Final Protocol PDF Version Final Protocol (PDF 402 KB)
Word Version Final Protocol (Word 947 KB)
MSAC OutcomesPublic Summary Document (PDF 152 KB)
Public Summary Document (Word 160 KB)

Meetings for this Application

Meeting Type:Date:
PASC12 and 13 December 2013
ESC 8 to 10 October 2014
MSAC 26 to 28 November 2014

Page currency, Latest update: 19 March, 2015