Recently Approved Device: GORE® CARDIOFORM Septal Occluder

Consumer Information on GORE® CARDIOFORM Septal Occluder - P050006/S060
FDA has recently approved the GORE® CARDIOFORM Septal Occluder to be marketed.

The GORE CARDIOFORM Septal Occluder is a device that is permanently implanted in the heart to close a patent foramen ovale (PFO). A PFO occurs when the foramen ovale, a naturally occurring hole located between the two upper chambers of the heart (the right atrium and the left atrium), does not close shortly after birth. If untreated, a PFO can allow a small amount of blood to pass from the right side of the heart to the left side of the heart. In rare cases, a PFO may lead to the occurrence of strokes.

The device includes an implant (occluder) and a delivery catheter (a small tube). The occluder is made of self-expanding, nickel-titanium (Nitinol) wires, covered in woven fabric. The occluder is shaped as two discs connected in the center. The occluder is compressed to a small size to allow it to pass through the delivery catheter so that physicians can implant it within the heart.