TCT-31 Title: Immediate and One Year U.S. IDE Trial Results of the New GORE® CARDIOFORM Septal Occluder for Transcatheter Closure of Secundum Atrial Septal Defects

The GORE® CARDIOFORM Septal Occluder (studied as GORE® Septal Occluder) was recently FDA approved for the transcatheter treatment of ostium secundum atrial septal defects. It is a low profile double disc device composed of a nitinol 5-wire frame, and covered with expanded polytetrafluoroethylene.