Device Dossier

MitraClip G4 System - Mitral valve clip

Device Dossier for MitraClip G4 System - Mitral valve clip (Heart valve clip, Class III, sponsor Abbott Vascular Division of Abbott Medical). ARTG…

Intended purpose

The MitraClip G4 System is intended for the reconstruction of the insufficient mitral valve through tissue approximation

Functional description

The MitraClip G4 System consists of the Clip Delivery System (CDS) and the Steerable Guide Catheter(SGC). The CDS is introduced into the body through a SGC which includes a dilator. The CDS is used to advance and manipulate the MitraClip G4 device for proper positioning and placement on the mitral valve leaflets.

TGA Public Summary