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Boston Scientific's WATCHMAN® Device Implanted in First Patients in Latin America
Date:11/16/2011

its ease of use."

The WATCHMAN Device is the most clinically studied product of its kind currently available.  In the multi-center, randomized PROTECT AF clinical trial, it proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for a combined measure of stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 800 patients.  The study also showed a 29 percent relative risk reduction in all stroke and a 90 percent relative risk reduction in hemorrhagic stroke compared to warfarin. Nearly 1,800 patients have now been recruited in WATCHMAN clinical trials with more than 2,700 patient-years of follow-up.  The WATCHMAN device is CE Marked and was commercialized outside the United States in 2009."The WATCHMAN device has been well received in many CE Mark countries and we look forward to beginning commercial launch in select Latin American markets this quarter," said Hank Kucheman, Chief Executive Officer for Boston Scientific.  "We are pleased to bring this technology to more customers and their patients worldwide."

Boston Scientific is currently enrolling U.S. patients in the PREVAIL study, a confirmatory study designed to gain Food and Drug Administration approval.  Enrollment is expected to be completed in the first quarter of 2012.  In the U.S., the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale.  The device was developed by Atritech, which Boston Scientific acquired in March 2011.  

About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.  

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