Device Dossier

Amplatzer™ Muscular VSD Occluder - Cardiac occluder

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

Intended purpose

The Amplatzer™ Muscular VSD Occluder is a device intended for the occlusion of a muscular ventricular septal defect. It is indicated for patients with a muscular ventricular septal defect.

Functional description

Under fluoroscopic and/or echocardiographic guidance, the occluder is deployed across the defect by releasing the distal disc, gently placing the occluder against the septum, then deploying the waist and proximal disc. The marker bands aid fluoroscopic visualization of the occluder. Echocardiography and/or angiography are used to assess the position for residual shunt and associated complications. Once proper placement is confirmed, the occluder is released and the delivery system is removed.

TGA Public Summary