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What is a PFO?What is an ASD?What is a VSD?
NMT Medical believes it is the first company to complete enrollment of a prospective, multi-center, randomized, controlled study that examines the potential relationship between patent foramen ovale (PFO) and stroke/transient ischemic attacks (TIA), called CLOSURE I.
CLOSURE I is designed to evaluate the effectiveness of transcatheter PFO closure using the NMT's proprietary STARFlex® septal repair implant. The PFO is a common heart defect that allows a right to left shunt or flow of venous blood directly into the arterial circulation while bypassing processing and filtering by the lungs. Of the 900 stroke and TIA patients enrolled in the study, half received PFO closure in a catheter-based procedure with NMT's STARFlex® septal repair implant and half are treated with best medical therapy alone.
More than 190 leading stroke neurologists and interventional cardiologists at approximately 95 centers in the United States, Canada and the United Kingdom are participating in the CLOSURE I study. The trial is being led by Principal Investigators Anthony Furlan, MD, and Mark Reisman, MD. Dr. Furlan is Chairman, Department of Neurology, Neurological Institute University Hospitals Case Medical Center, and Case Western Reserve University School of Medicine in Cleveland. Dr. Reisman is Director, Cardiovascular Research and Director, Cardiac Catheterization Lab, Swedish Heart and Vascular Institute in Seattle.
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"Over time the BioSTAR® scaffold will be replaced with the patient's native tissue."
Michael J. Mullen, MB, BS, MRCP, MD, Consultant Cardiologist, The Heart Hospital, London, United Kingdom