Physicians have been performing catheter-based procedures in the heart to make diagnoses and treat heart conditions for many years. Catheter- based closure of an ASD or PFO involves the placement of a permanent implant, such as the GORE® CARDIOFORM Septal Occluder, using a minimally invasive procedure.

The GORE® CARDIOFORM Septal Occluder is intended for the closure of an ASD and PFO using cardiac catheterization. It is a permanent implant consisting of a wire frame covered with a thin ePTFE membrane. The wire frame is made of a platinum-filled nickel-titanium (Nitinol) alloy. The ePTFE material, invented and manufactured by Gore has been used in open-heart surgery for more than 35 years with a history of proven safety in medical implants.