Device Dossier

Amplatzer Amulet Left Atrial Appendage Occluder - Cardiac occluder

Device Dossier for Amplatzer Amulet Left Atrial Appendage Occluder - Cardiac occluder (Cardiac occluder, Class III, sponsor Abbott Medical). ARTG record,…

Intended purpose

The Amplatzer Amulet Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have non-valvular atrial fibrillation.

Functional description

The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires that permit visibility during fluoroscopy.

TGA Public Summary