Device Dossier
TriClip Steerable Guide Catheter - Catheter, intravascular, guiding
Device Dossier for TriClip Steerable Guide Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Abbott…
- GMDN category: Catheter, intravascular, guiding
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 Steerable Guide Catheter(TSGC) is used tointroduce the Triclip Delivery System(TCDS) into the rightside of the heart. The TSGC is also used to position andorient the TCDS to the appropriate location above thetricuspid valve. the Dilator is used for the introduction of theTSGC into the femoral vein and right atrium.The outersurface of the TSGC has a hydrophilic coating.