Device Dossier
Gore Cardioform Septal Occluder - Cardiac Occluder
Device Dossier for Gore Cardioform Septal Occluder - Cardiac Occluder (Cardiac occluder, Class III, sponsor W L Gore & Associates). ARTG record, intended…
- GMDN category: Cardiac occluder
Intended purpose
The Gore Cardioform Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects (ASDs), such as ostium secundrum and patent foramen ovale (PFOs).
Functional description
A platinum-filled nickel-titanium wire frame covered with hydrophilic coated ePTFE and a catheter delivery system. When fully deployed, the occluder assumes a left and right atrial disc configuration to bridge septal defects.