Device Dossier

MitraClip G4 Clip Delivery System - Mitral valve clip

Device Dossier for MitraClip G4 Clip Delivery System - Mitral valve clip (Heart valve clip, Class III, sponsor Abbott Vascular Division of Abbott…

Intended purpose

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

Functional description

A sterile implantable device intended for the reconstruction of an insufficient mitral valve and reduction of mitral valve regurgitation through the fixed approximation of the mitral valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. The disposable CDS is typically included with the mitral valve clip.

TGA Public Summary