Amplatzer Septal Occluder - Cardiac occluder

Intended purpose

The Amplatzer Septal Occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (ASDs) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (RV) volume overload (ie, 1.5:1 degree of left-to-right shunt or RV enlargement).

Functional description

A self-expanding nitinol mesh, double-disc occlusion device for use in atrial septal defects. The 2 discs are connected by a short waist with a waist diameter that corresponds to the atrial defect size. To increase its closing ability, the device is filled with polyester fabric that is securely sewn to each disc by a polyester thread. Radiopaque marker bands at each end of the device provide visualization under fluoroscopy.