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…
- GMDN category: Cardiac occluder
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.