AMPLATZER Amulet Left Atrial Appendage Occluder - Cardiac occluder

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Abbott Medical Australia Pty Ltd

Klass:

Class III

Tillverkad av:

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

Terapiområde:

45418 - Cardiac occluder

Terapeutiska indikationer:

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.

Bemyndigande status:

A

Tillstånd datum:

2013-10-23