MitraClip™ G5 Delivery System - Heart valve clip

Intended purpose

The MitraClip™ G5 System is intended for reconstruction of the insufficient mitral valve through tissue approximation. The MitraClip™ G5 System is indicated for patients with symptomatic primary (degenerative) or secondary (functional) significant mitral regurgitation (MR ≥ 2+).

Functional description

A sterile implantable device intended for the reconstruction of an insufficient mitral heart valve and reduction of 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.