Device Dossier

Amplatzer PI Muscular VSD Occluder - Cardiac occluder

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

Intended purpose

The Amplatzer PI Muscular VSD Occluder is percutaneous, transcatheter, ventricular septal defect closure devices intended to close acquired muscular ventricular septal defects occurring in patients presenting with acute post myocardial infarction. This device is also intended to close any post-surgical, residual shunts occurring in this same patient group.

Functional description

A self expandable, double disc devices made from a Nitinol wire mesh. The two discs are linked together by a short cylindrical waist corresponding to the size of the Ventricular Septal Defect. In order to increase its closing ability, the discs and waist are filled with polyester fabric. The polyester fabric is securely sewn to the device by polyester thread.

TGA Public Summary