Device Dossier
GORE® CARDIOFORM ASD Occluder - Cardiac occluder
Device Dossier for GORE® CARDIOFORM ASD Occluder - Cardiac occluder (Cardiac occluder, Class III, sponsor W L Gore & Associates). ARTG record, intended…
- GMDN category: Cardiac occluder
Intended purpose
The GORE® CARDIOFORM ASD Occluder is a permanently implanted medical device intended to close an ostium secundum atrial septal defect (ASD).
Functional description
The GORE® CARDIOFORM ASD Occluder (System) consists of an implantable occluder and a delivery system. The occluder is comprised of a platinum-filled nickel-titanium (Nitinol) wire frame covered with expanded polytetrafluoroethylene (ePTFE). The ePTFE includes a hydrophilic surface treatment to facilitate echocardiographic imaging of the occluder and surrounding tissue during implantation.