In approximately one out of every four individuals, the hole in the heart will remain open after birth. This is called a patent foramen ovale, or PFO. In most people, a PFO creates no symptoms and requires no treatment. However, in a small minority, a PFO may permit blood clots to pass from the right side of the heart to the left side, possibly leading to a stroke.
The GORE® CARDIOFORM Septal Occluder is approved for atrial septal defects (ASD) and now FDA approved for patent foramen ovale (PFO) closure to reduce the risk of recurrent ischemic stroke in select patients.*
* Refer to Instructions For Use for complete indication.