AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder

Available from:

Abbott Medical Australia Pty Ltd

Class:

Class III

Manufactured by:

AGA Medical Corporation 5050 Nathan Lane North, Plymouth, MN, 55442 United States Of America

Therapeutic area:

45418 - Cardiac occluder

Therapeutic indications:

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. 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 nonvalvular atrial fibrillation.

Authorization status:

A

Authorization date:

2013-10-23