Cosgrove-Edwards Annuloplasty System with Template/Lanyard for Valvuloplasty - Mitral/tricuspid annuloplasty ring

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Edwards Lifesciences Pty Ltd

Klasse:

Class III

Produsert av:

Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America

Terapeutisk område:

45578 - Mitral/tricuspid annuloplasty ring

Indikasjoner:

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. 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.

Autorisasjon status:

A

Autorisasjon dato:

2009-01-21