Device Dossier

Amplatzer Duct Occluder II - Cardiac occluder

Device Dossier for Amplatzer Duct Occluder II - Cardiac occluder (Cardiac occluder, Class III, sponsor Abbott Medical). ARTG record, intended purpose,…

Intended purpose

The Amplatzer Duct Occluder II is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.

Functional description

A self-expanding nitinol mesh device for the occlusion of the patent ductus arteriosus (PDA). The device configuration is a central waist with 2 retention discs. The central waist is designed to fill the ductus and the 2 retention discs are designed to be deployed in the pulmonary artery and aortic sides of the ductus. The device is available in 2 lengths. The radiopaque marker bands at each end of the device provide visual guidance under fluoroscopy.

TGA Public Summary