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Boston Scientific Updates PREVAIL Late Breaking Clinical Trials Presentation
Date:3/6/2013

NATICK, Mass., March 6, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) PREVAIL clinical trial results will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology, and will include all three co-primary endpoints that evaluate safety and efficacy of the WATCHMAN® Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial fibrillation versus long-term warfarin therapy.  This will be the first time all three co-primary endpoints in the PREVAIL study will be presented.

The preliminary results of the PREVAIL Trial will be presented on March 9 in San Francisco, California by David R. Holmes Jr. , M.D., Mayo Clinic, Rochester, Minn., at 9:10 a.m. PT, in the Moscone Center, South, Esplanade Ballroom.

Specifically, Dr. Holmes will present preliminary analysis on the following co-primary endpoints:

  • Acute (7-day) occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention
  • Comparison of composite of stroke, systemic embolism, and cardiovascular/unexplained death at 18 months follow-up
  • Comparison of ischemic stroke or systemic embolism occurring from greater than 7 days post randomization  to 18 months follow-up

"This is truly a late-breaking clinical trial presentation," said Kenneth Stein , M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific.  "The last patient six-month follow-up occurred in January and the team has been working diligently to complete the preliminary analysis of the data.  The acute procedural results were completed first, and we announced earlier this week that those results would be presented.  We are pleased to announce that the preliminary analysis of the other two endpoints will now be presented as well.  The final fully monitored and adjudicated analysis will be completed in the coming weeks and is expected to be used to support our comprehensive clinical module PMA filing of the WATCHMAN device.  This filing is also expected to include Protect AF four-year outcomes data, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data update." 

The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009.  It is already commercially available in 40 countries worldwide.  In the United States, WATCHMAN is an investigational device, limited by applicable law to investigational use and not available for sale.  Results from the PREVAIL confirmatory study are expected to be submitted for approval by the U.S. Food and Drug Administration (FDA).  The device was developed by Atritech, which Boston Scientific acquired in March 2011.  Please visit http://www.bostonscientific.com/watchman-eu/ for more information.  Images of the WATCHMAN device are available for download at http://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.

Both the Mayo Clinic and Dr. Holmes have a financial interest in technology related to this research. 

The clinical data results are embargoed until the time of the scientific presentation.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. 

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACT:  

Steven Campanini
508-652-5740 (office)
214-546-5034 (cell, March 7 - March 11)
Global Media Relations
Boston Scientific Corporation
media@bsci.com

Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

 


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