Device Dossier

TriClip™ G5 Delivery System - Heart valve clip

Device Dossier for TriClip™ G5 Delivery System - Heart valve clip (Heart valve clip, Class III, sponsor Abbott Vascular Division of Abbott Medical). ARTG…

Intended purpose

The TriClip™ G5 System is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. The TriClip™ G5 System is indicated for patients with severe, symptomatic tricuspid regurgitation.

Functional description

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

TGA Public Summary