Device Dossier

Amplatzer™ Talisman™ PFO Occluder - Cardiac occluder

Device Dossier for Amplatzer™ Talisman™ PFO Occluder - Cardiac occluder (Cardiac occluder, Class III, sponsor Abbott Medical). ARTG record, intended…

Intended purpose

The Amplatzer™ Talisman™ PFO Occluder is intended to close a patent foramen ovale to reduce the risk of recurrent ischemic stroke in patients who have had an ischemic stroke due to a presumed paradoxical embolism.

Functional description

The Amplatzer™ Talisman™ PFO Occluder is a self-expanding device configured with a central waist with two retention discs. The central waist is placed into the defect which centralises the device around the flap-like patent foramen ovale. The waist allows each disc to articulate in relation to the defect and conform to the septal wall. The device is delivered percutaneously via the end screw attached to the proximal disc, through a delivery sheath.

TGA Public Summary