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PreSCD II Registry Shows ICDs Lead to 44 Percent Reduction in Mortality for Heart Attack Survivors

NATICK, Mass. and BARCELONA, Sept. 1 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced long-term data from the Prevention of Sudden Cardiac Death II registry (PreSCD II). The results found that implantable cardioverter defibrillators (ICDs) were associated with a 44 percent reduction in all cause mortality (p=0.053) when implanted in patients following myocardial infarction (heart attack). The mortality reduction trend was also observed in high-risk patients with severely reduced heart function. Analysis of the data was presented by Professor Heinz Voller, M.D., Klinikum am See, Ruedersdorf, Germany at the annual European Society of Cardiology (ESC) Congress in Barcelona.

Heart attack survivors have an increased risk for sudden cardiac death, and patients with impaired left ventricular function in particular benefit from protection by an ICD. Major clinical trials such as MADIT II suggest that ejection fraction -- a measure of the heart's pumping capacity -- should be used to characterize risk and determine which patients should receive an ICD. Data from PreSCD II revealed that within the highest risk subgroup (ejection fraction <= 30%), only 22 percent of patients were prescribed ICD therapy.

"The PreSCD II data provide real-world confirmation of the findings of randomized clinical trials that have shown ICDs reduce mortality following a heart attack," said Professor Voller. "In addition, PreSCD II confirms that actual ICD implantation rates for the highest risk subgroup were lower than those recommended by current guidelines and other study results. This is a significant concern because the mortality reduction associated with an ICD was greatest among these patients. We were also interested to observe a survival benefit that increased with the time interval between heart attack and ICD implantation."

The PreSCD II registry enrolled 10,612 heart attack survivors between 2002 and 2005 in 19 centers in Germany. It has been endorsed by the German Society of Cardiology and the German Society for Prevention and Rehabilitation.

Boston 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:

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This press release contains forward-looking statements within the meaning of 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 clinical trials, scientific activities, product performance, competitive offerings and growth investment. 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 thereafter. 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.

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