Application Detail

Status

Closed

Description of Medical Service

The 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 Condition

The 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

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

Final Protocol (PDF 402 KB)
Final Protocol (Word 947 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 152 KB)
Public Summary Document (Word 160 KB)

Meetings for this Application

PASC

12 to13 December 2013

ESC

8 to 10 October 2014

MSAC

26 to 28 November 2014