Amplatzer™ P.I. Muscular VSD Occluder - Cardiac occluder

Intended purpose

The Amplatzer™ P.I. Muscular VSD Occluder is a device intended for the occlusion of a post-infarct muscular ventricular septal defect.It is indicated for patients with a muscular ventricular septal defect following a myocardial infarction.

Functional description

Under fluoroscopic and/or echocardiographic guidance, the occluder is deployed across the defect by releasing the distal disc, pulling the occluder gently against the septum, and deploying the waist and proximal disc. The marker bands aid fluoroscopic visualization. Once the occluder is in place, echocardiography and/or angiography are used to assess position and residual shunt. When proper placement is confirmed, the occluder is released and delivery system is removed.