Because of the increased risk of stroke in persons with a PFO, treatment with anticoagulant (blood-thinning) medications such as aspirin and warfarin may be prescribed. However, there is evidence that the embolism occurs through the opening itself. Therefore, direct closure of the PFO is being increasingly performed in selected patients - especially those with a history of recurrent unexplained strokes due to presumed paradoxical embolism and where pharmaceutical treatment has been ineffective.

PFO closure may be achieved through open heart surgery or through a transcatheter procedure using an occlusion device. The surgical approach involves the closing of the PFO with a double-continuous suture. This procedure is expensive and invasive and often painful. Therefore, the transcatheter approach is used whenever possible.

Devices used for PFO closure include the Amplatzer® PFO occluder, and the CardioSeal® or Helex® devices.

The transcatheter PFO occlusion procedure normally takes from 2 to 4 hours and is performed in a catheterization laboratory. The catheter is inserted in the femoral vein in the groin area, which is numbed with a local anesthetic. Sometimes, general anesthesia or sedation by IV is prescribed.

It is very rare for the body to react negatively to the occlusion device. A few days after the procedure, the patient's own body tissues will begin to envelope the closure device, a process which is usually complete within 6 months. Even though the PFO is closed by the device, patients are maintained on warfarin and/or aspirin because of the risk of recurrent stroke.