Device Dossier

SimuForm™ Semi-Rigid Annuloplasty Ring Model 7800RR - Mitral/tricuspid annuloplasty ring, open-surgery

Device Dossier for SimuForm™ Semi-Rigid Annuloplasty Ring Model 7800RR - Mitral/tricuspid annuloplasty ring, open-surgery (Mitral/tricuspid annuloplasty…

Intended purpose

The intended purpose of the SimuForm annuloplasty ring is to restore unidirectional blood flow through the mitral annulus by repairing a diseased or damaged mitral valve.

Functional description

The SimuForm ring provides semi-rigid posterior remodeling to the mitral annulus while offering a flexible anterior portion to accommodate motion. The SimuForm annuloplasty ring may be used for reconstruction and/or remodeling of pathological mitral valves to repair annual dilation.

TGA Public Summary