GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Inclusion Criteria:

• Diagnosed with an ischemic stroke presumed to be an embolic stroke of undeterminedsource (ESUS) verified by a neurologist within the last 365 days prior toenrollment.

• Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubblestudy utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shuntingduring Valsalva maneuver.

• Patient is able to tolerate antiplatelet therapy

• Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

• History of or ongoing atrial fibrillation/flutter

• Other co-morbidities including, but not limited to, mural thrombus, dilatedcardiomyopathy, cardiac prosthetics (valves), severe native valve disease (includingmitral valve stenosis), severe ventricular wall motion abnormalities, aorticdissection, significant atherosclerosis, vasculitis, pre-existing non-vascularneurologic disorders, pulmonary arteriovenous malformations, prior intracranialhemorrhage, severe disability related to prior stroke, autoimmune disorders thatwould increase the risk of stroke or thromboembolism, or associated with increasedrisk of infection or procedural complications, in the opinion of the investigator,left ventricular ejection fraction of <40%, coexistent cause or intra-cardiacshunting (e.g. VSD or ASD)

• Previous Myocardial Infarction

• Rankin Scale sore greater than or equal to 3 at the time of procedure

• Active infection that cannot be treated successfully prior to enrollment

• Neurological deficits not due to stroke that may affect the patient's neurologicassessments

• Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolledsystemic hypertension or pulmonary hypertension at the time of screening orprocedure

• Sensitivity or contraindication to all proposed medical treatments or any devicecomponents

• Pregnant, lactating, or intent on becoming pregnant through 24 months afterenrollment.

• Indications outside the parameters accepted for placement of GSO, includingextensive congenital cardiac anomalies and defect diameters considered too large forclosure with the device.

• Atrial septal anatomy that is expected to necessitate placement of more than oneGORE® CARDIOFORM Septal Occluder

• Need for concomitant procedure(s) that may confound detection of adverse eventsrelated to device placement

• Note: Additional Exclusion Criteria may apply