Inclusion Criteria:

• Subject is between 18 and 65 years old
• Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.

• Subjects with one or more of the following:

  • history of cryptogenic stroke, transient ischemic attack (TIA) or embolism due to presumed paradoxical embolism through a PFO; or
  • history of severe migraine headaches, despite attempted treatment with available migraine medications, for whom other specific causes of migraine headache, such as underlying disease or medications, have been ruled out; or
  • history of severe decompression illness.
• Negative pregnancy test in women who are of child-bearing potential
• Signed Informed Consent form

Additional Inclusion Criteria for Migraine Subjects:

• Onset of migraine before age of 50 years
• History of migraine > 1 year
• Migraine frequency greater than 1 migraine per month

Exclusion Criteria:

• Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
• Active endocarditis, or other infections producing a bacteremia
• Presence of atrial septal defect(s) or fenestrations which allow shunting
• Presence of implanted cardiac valves, pacemakers, cardioverters/defibrillators (ICDs) or vena cava filters.
• Subjects with coagulation disorders or bleeding disorders including gastric ulcers, who are unable to take antiplatelet or anticoagulant therapy
• Subjects with an intra-cardiac mass, tumor, clots or vegetation
• Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
• Presence of conduction abnormality requiring pharmacologic or electrical therapy intervention or 1st degree block
• Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry
• Religious or other beliefs which would prevent subjects from following all physician directed instructions or prevent compliance with protocol required medications and follow-ups.
• Hemodynamic instability or shock
• History of diabetes requiring treatment with insulin

Additional Exclusion Criteria for Cryptogenic Stroke Subjects:

• History of stroke or TIA within the past 14 days
• Source of stroke other than paradoxical embolization

Additional Exclusion Criteria for Migraine Subjects:

• Seizure disorder
• Other organic central nervous system disease
• Headache as a result of traumatic head or neck injury
• Evidence of alcohol, drug or substance abuse within the previous year