Prospective Multi Center Comparative parallel concurrent study of the NobleStitch EL as compared to the FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale (PFO) to prevent recurrent Ischemic Stroke.
The purpose of the study is to collect data on the NobleStitch EL suture mediated closure system to safely and effectively close a Patent Foramen Ovale (PFO) to reduce the risk of recurrent Ischemic Stroke. The data collected will be compared to PFO closure using the FDA approved Amplatzer Occluder device.