“The analysis of the data from patients in the per-protocol group and the as-treated group provide compelling evidence that PFO closure with the AMPLATZER PFO Occluder is superior to medical management from both clinical and statistical perspectives,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The totality of evidence from this study, including the strong performance and safety profile of the device, demonstrates the compelling clinical benefits of closure versus medical management in reducing the likelihood of recurrent stroke in this patient population.”According to the World Health Organization (WHO) an estimated 15 million people worldwide suffer from stroke each year. Of these, 5 million die and another 5 million are left permanently disabled, placing a burden on families and communities. It is estimated that 87 percent of all strokes are ischemic strokes, which occur when blood clots block the blood vessels to the brain. Up to 40 percent of ischemic strokes are classified as cryptogenic, which means the cause of the stroke is unknown.
Photo Of AMPLATZER PFO Occluder. (Photo: St. Jude Medical, Inc.)
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