Presentation of Preliminary Results From Boston Scientific PREVAIL Clinical Trial Now Available WATCHMAN® Device Continues to Demonstrate Positive Clinical Outcomes for Patients with Atrial Fibrillation
NATICK, Mass., March 9, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the preliminary analysis of the PREVAIL clinical trial data is now available on TCTMD at http://www.tctmd.com/show.aspx?id=118115. PREVAIL evaluates the safety and efficacy of the WATCHMAN® Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial fibrillation versus long-term warfarin therapy.
The company inadvertently broke the American College of Cardiology (ACC) embargo policy surrounding the PREVAIL clinical trial data, which were to be presented at the 62nd Annual Sessions of the American College of Cardiology in the Late-Breaking Clinical Trial presentation on Saturday, March 9, 2013. As a result of the inadvertent error, ACC canceled the presentation.
"Boston Scientific considers scientific exchange in a peer-reviewed setting to be of the utmost importance and we deeply regret that the data were not shared at ACC," said Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific.
In the United States, WATCHMAN is an investigational device, limited by applicable law to investigational use and not available for sale.
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 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.
214-546-5034 (March 9-11 during ACC)
Global Media Relations
Boston Scientific Corporation
Boston Scientific Corporation
SOURCE Boston Scientific Corporation