Device Dossier

Simulus Flexible Annuloplasty Band 700FC - Mitral/tricuspid annuloplasty ring

Device Dossier for Simulus Flexible Annuloplasty Band 700FC - Mitral/tricuspid annuloplasty ring (Mitral/tricuspid annuloplasty ring, Class III, sponsor…

Intended purpose

Intended for use in patients undergoing surgery for diseased or damaged mitral or tricuspid valves, to provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Functional description

The Band is marked at three points by coloured sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the Band midpoint. The individual Band size (23 - 39 mm in 2-mm increments) refers to the inner circumference between the green trigone markers. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualisation. The Band is mounted to a holder to ease positioning and implantation.

TGA Public Summary