Device Dossier
Cosgrove-Edwards Annuloplasty System with Template/Lanyard for Valvuloplasty - Mitral/tricuspid annuloplasty ring
Device Dossier for Cosgrove-Edwards Annuloplasty System with Template/Lanyard for Valvuloplasty - Mitral/tricuspid annuloplasty ring (Mitral/tricuspid…
- GMDN category: Mitral/tricuspid annuloplasty ring
Intended purpose
The Cosgrove-Edwards Annuloplasty System, model 4600, is intended to be used in mitral and tricuspid valve repairs for patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines and prevent further dilatation of the annulus.
Functional description
The Cosgrove-Edwards Annuloplasty System consists of two primary components ? the implantable flexible Annuloplasty band and the template/lanyard assembly. The implantable Annuloplasty band is composed of a silicone rubber strip compounded with barium sulphate to enable radiographic visualization. The silicone rubber strip is covered with polyester velour cloth which is sewn together with a single seam. The system can be used in mitral and tricuspid valve repairs.