Device Dossier

Amplatzer Multifenestrated Septal Occluder - Cribriform - Cardiac occluder

Device Dossier for Amplatzer Multifenestrated Septal Occluder - Cribriform - Cardiac occluder (Cardiac occluder, Class III, sponsor Abbott Medical). ARTG…

Intended purpose

The Amplatzer Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (Cribriform) atrial septal defects. Patients indicated for ASD closure have echocardiographic evidence of fenestrated ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or RV enlargement).

Functional description

A self expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short connecting waist. In order to increase its closing ability, the discs are filled with polyester fabric. The polyester fabric is securely sewn to each disc by polyester thread.

TGA Public Summary