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Boston Scientific Corporation : 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

05/11/2012 | 08:05am US/Eastern
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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 regularly and pump blood efficiently. Patients in atrial fibrillation are at greater risk for stroke due to the migration of clots formed in the left atrial appendage (LAA). Anticoagulants such as warfarin have traditionally been the only therapy for reducing stroke risk in these patients. The Boston Scientific percutaneously delivered WATCHMAN Device is an alternative to long-term anticoagulation in patients eligible for anticoagulant therapy. It is designed to close the LAA, thereby preventing clots forming within the appendage and being dislodged into the bloodstream where they can potentially cause a stroke.

"Findings from the ASAP Study are promising in that closure of the LAA with the WATCHMAN Device produced a significant reduction in the expected ischemic stroke rate for this patient population," said Dr. Reddy. "These results are very impressive and show potential for an effective device-based solution for higher-risk patients with limited pharmacologic options to reduce their risk of stroke."

For patients in the ASAP Study, the average baseline CHADS2 score of 2.8 equated to a predicted ischemic stroke rate of approximately 7.1 percent per year. The observed rate of ischemic stroke for patients implanted with the WATCHMAN Device was 1.7 percent per year, a 75 percent reduction in stroke risk from the predicted stroke rate based on the CHADS2 score (p<0.01). The corresponding upper confidence bound yielded a stroke rate of 4.4 percent per year, lower than the predicted stroke rate of 7.1 percent.

Stroke rates in the ASAP study were similar to those observed in the PROTECT AF study, which assessed similar subjects not contraindicated to warfarin. In the multi-center, randomized PROTECT AF trial, the WATCHMAN Device proved to be non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 707 patients.

The WATCHMAN Device was approved for marketing in Europe and other CE Mark countries in 2009. Boston Scientific is currently enrolling U.S. patients in the PREVAIL study, a confirmatory study designed to gain U.S. Food and Drug Administration approval. Enrollment is expected to be completed in the second quarter of 2012. The WATCHMAN Device is contraindicated in patients who are not eligible for anticoagulation therapy. 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. For more information, visit www.Atritech.net.

For more news about Boston Scientific at the Heart Rhythm Society 33rd Annual Scientific Sessions, please follow us on Twitter @BostonSci.

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

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 markets for our products and launch cadence, regulatory approvals, clinical studies, trials and outcomes, 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) during the conference
                                    Media Relations
                                    Boston Scientific Corporation
                                    steven.campanini@bsci.com

                                    Emily Hyman
                                    415-515-7106  (cell) during the conference
                                    Media Relations
                                    Weber Shandwick
                                    ehyman@webershandwick.com

                                    Sean Wirtjes
                                    508-652-5305 (office)
                                    Investor Relations
                                    Boston Scientific Corporation
                                    investor_relations@bsci.com

SOURCE Boston Scientific Corporation

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