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Study of First-in-Class WATCHMAN® Device Shows 75 Percent Reduction in Stroke Risk in Patients with Atrial Fibrillation Not Eligible for Oral Anticoagulation Therapy
Date:5/11/2012

NATICK and BOSTON, Mass., May 11, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial Appendage Closure (LAAC) device.  The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.  Vivek Reddy, M.D., Director of Cardiac Arrhythmia Service at Mount Sinai Medical Center in New York and Coordinating Investigator of the study presented results today during a late-breaking session at the Heart Rhythm Society's 33rd Annual Scientific Sessions in Boston.

The prospective multi-center ASAP Study evaluated 150 patients with contraindications to warfarin, who were implanted with the WATCHMAN Device and treated with dual antiplatelet therapy for six months post-procedure.  Subjects were followed for a mean average of 14.4 months.  The study employed the widely recognized CHADS2 risk stratification score, which provides a clinical prediction tool for estimating the risk of stroke in patients with atrial fibrillation.  The CHADS2 score has been validated by numerous studies and is regularly used to determine whether treatment is required with anticoagulation or antiplatelet therapy.

"WATCHMAN is the most studied LAA closure device with more than 2,000 patients enrolled in prospective studies and nearly 4,000 patient-years of follow up," said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific.  "This novel device has been well received in more than 30 countries where it offers a safe and effective alternative to long-term treatment with oral anticoagulants."

Atrial fibrillation affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regu
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SOURCE Boston Scientific Corporation
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