Application Detail

Status

Open

Description of Medical Service

The proposed medical service is the endovascular insertion of a Flow Diversion Device (FDD) within the parent vessel spanning the neck of the UIA. The FDD functions by reducing blood flow from the parent artery into the aneurysm - as a result blood in the aneurysm stagnates and undergoes thrombosis – i.e. embolizes – and the aneurysm resolves. FDD was originally developed to treat intracranial aneurysms with complex morphologies. These are challenging to treat with endovascular coiling: outcomes have been poor with suboptimal aneurysm occlusion and recurrence requiring re-intervention in complex cases. FDD is much less invasive than microsurgical clipping which requires a craniotomy. There is a high clinical need for a safe and effective procedure to be listed on the Medicare Benefits Schedule (MBS) that overcomes the shortcomings of current treatments. Importantly, FDD represents a treatment option in a small proportion of patients currently left untreated due to the complexity of the aneurysm.

Description of Medical Condition

An intracranial aneurysm, also known as a cerebral or brain aneurysm, is an abnormal, localised dilation that balloons or bulges from an artery that supplies blood to the brain. The aneurysm occurs when a weakness develops in the wall of an artery supplying blood to the brain. UIAs are often asymptomatic and are identified incidentally through imaging for symptoms unrelated to the UIA. Large or giant aneurysms frequently present with symptoms of mass effect on the cranial nerves, such as headache, nausea/vomiting, visual disturbances or loss of consciousness. The prevalence of UIAs in a population without comorbidities is estimated as 3.2%. The majority of UIAs remain stable, however, a small proportion will eventually rupture causing aneurysmal bleeding in the brain. The clinical consequences of a ruptured aneurysm are serious and associated with significant morbidity and mortality.

Reason for Application

Amendment to MBS item

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1104 KB)
Appllication Form (Word 535 KB)

Consultation Survey

Consultation Survey (PDF 305 KB)
Consultation Survey (Word 508 KB)

PICO Confirmation

PICO confirmation (PDF 1639 KB)
PICO confirmation (Word 508 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 724 KB)
Public Summary Document (Word 364 KB)

Meetings for this Application

PASC

6-7 December 2018

ESC

10-11 October 2019

MSAC

28-29 November 2019