TriClip G4 Clip Delivery System - Mitral valve clip

Intended purpose

The TriClip™ G4 System is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. The TriClip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a Heart Team

Functional description

The TriClip G4 Implant is a percutaneously implantedmechanical implant that grasps and coapts the tricuspid valveleaflets resulting in fixed approximation of the tricuspidleaflets throughout the cardiac cycle.The Triclip G4 implantcomes preloaded on a TriClip Delivery System (TCDS).TheTCDS is used to advance and manipulate the implant forproper positioning and placement on the tricuspid valveleaflets.The TCDS has a hydrophilic coating and is designedto deploy the implant in multiple steps