Applications

1542 – Endovascular insertion of flow diversion device (FDD) for the treatment of unruptured intracranial aneurysms (UIAs)

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

Amendment to MBS item

Service or technology in this application

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.

Type: Therapeutic

Medical condition this application addresses

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.

Meetings to consider this application

  • PASC meeting: 6 to 7 December 2018
  • ESC meeting: 10 to 11 October 2019
  • MSAC meeting: 28 to 29 November 2019