Amplatzer™ Septal Occluder - Cardiac occluder

Intended purpose

The Amplatzer™ Septal Occluder is intended for the nonsurgical occlusion of ostium secundum atrial septal defects or fenestrations. It is indicated for use in patients with ostium secundum atrial septal defect or fenestrations who have clinical evidence of right ventricular (RV) volume overload (such as 1.5:1 degree of left-to-right shunt, or RV enlargement on echocardiography), or in patients who have undergone a fenestrated Fontan procedure and require closure of the fenestration.

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 for visualization under fluoroscopy.