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New Four-Year Data From Boston Scientific Demonstrated WATCHMAN® Device Was Superior To Warfarin For Mortality And Primary Efficacy In Patients With Atrial Fibrillation In Long Term Follow-Up Of The PROTECT AF Trial

NATICK, Mass., May 9, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports that the four-year follow-up data from the PROTECT AF clinical trial demonstrated the WATCHMAN® Left Atrial Appendage (LAA) Closure device was statistically superior to warfarin for preventing cardiovascular death, all-cause stroke and systemic embolization.  The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.  The data were presented today as a late-breaking clinical trial at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions in Denver, by Vivek Reddy, M.D., a principal investigator of the PROTECT AF trial, and Professor of Medicine and Director of the Cardiac Arrhythmia Services at Mount Sinai School of Medicine in New York.  The abstract is titled, " Long Term Results of PROTECT AF: The Mortality Effects of Left Atrial Appendage Closure versus Warfarin for Stroke Prophylaxis in AF."

Atrial fibrillation (AF) is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications.  The condition affects approximately 2.7 million Americans and 15 million people worldwide, and is the most common cause of disabling stroke.  A primary treatment goal for AF patients is to reduce the risk of blood clots causing stroke.  Patients with AF and additional risk factors for stroke are commonly prescribed blood thinning medications, also known as anticoagulants, like warfarin, to prevent blood clots from forming in the heart.  However, due to blood monitoring requirements, dietary restrictions, side effects and an increased risk of serious bleeding, many patients are unable or unwilling to take these medications for long periods of time.  In contrast, the WATCHMAN device is designed to close off the LAA, a major source of clots in patients with AF, and reduce the risk of stroke, potentially eliminating the need for long term use of blood-thinning medications.

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