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…
- GMDN category: Heart valve clip
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.