Amplatzer Valvular Plug III - Cardiac occluder

Intended purpose

The Amplatzer Valvular Plug III is intended for percutaneous, transcatheter closure of a paravalvular leak that has developed after an aortic or mitral surgical valve implant procedure.

Functional description

The Amplatzer™ Valvular Plug III is a self-expanding, multi-layered oblong-shaped (oval) occlusion device made from Nitinol wire braid, with a flexible Nitinol waist. The device has a proximal retention disc that is attached to a central lobe with a distal retention disc; each disc is designed to fit on either side of a paravalvular leak (PVL) defect.