Device Dossier

SimuPlus™ Flexible Annuloplasty Ring Model 7700FR - Mitral/tricuspid annuloplasty ring, open-surgery

Device Dossier for SimuPlus™ Flexible Annuloplasty Ring Model 7700FR - Mitral/tricuspid annuloplasty ring, open-surgery (Mitral/tricuspid annuloplasty…

Intended purpose

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

Functional description

The SimuPlus flexible rings are designed to stabilize the mitral annulus without the use of rigidity: Providing support to both the posterior and anterior portions of the mitral annulus. The SimuPlus annuloplasty ring may be used for reconstruction and/or remodeling of pathological mitral valves to repair annual dilation.

TGA Public Summary