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ALTITUDE Clinical Data Show ICD Therapy Saves Lives Without Mortality Increase from Device Shock

Thu, 05/05/2011 - 9:33am
Boston Scientific

NATICK, Mass. and SAN FRANCISCO, May 5, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of its ALTITUDE® Clinical Science program, which demonstrated that defibrillator therapy saves lives from lethal arrhythmias without an increase in mortality due to defibrillator shock.  Instead, the authors found that increased mortality risk associated with these shocks is not attributed to the defibrillator shock itself, but rather entirely related to the underlying medical condition leading to atrial and ventricular arrhythmias.

ALTITUDE analyzes outcomes data from patients monitored by the LATITUDE® Patient Management system.  Brian Powell, M.D., Assistant Professor of Medicine at the Mayo Clinic, presented results during a late-breaking trial session at the Heart Rhythm Society Scientific Sessions in San Francisco.

"The ALTITUDE Clinical Science program continues to provide groundbreaking data on survival after device implantation and has greatly advanced our understanding of the natural history of arrhythmias and how device programming influences patient outcomes," said Leslie Saxon, M.D., Chief of Cardiovascular Medicine at University of Southern California and chairperson of the ALTITUDE physician panel.  "What these data tell us is that patients who have atrial fibrillation or ventricular arrhythmias and receive shocks should be monitored and treated aggressively.  While shocks should only be delivered when necessary, it is encouraging to know that shock therapy from these devices does not increase mortality."

The ALTITUDE program enhances physician understanding of device therapy, outcomes and disease progression in a real-world setting for device patients followed by the LATITUDE® Patient Management system.  The system lets physicians conduct remote follow-up of implantable cardiac device patients to monitor specific device information and heart health status.  The system also detects clinical events between scheduled in-clinic visits and sends relevant data directly to physicians.  Since its introduction in 2006, Boston Scientific has enrolled more than 190,000 patients.  

Boston Scientific's latest implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) feature AcuShock™, an advanced technology that can distinguish between a potentially lethal heart arrhythmia and a non-lethal arrhythmia within seconds, which can help to minimize inappropriate and unnecessary shocks.

"Our devices deliver painless pacing therapy far more than shocks to treat potentially lethal arrhythmias, while demonstrating extremely low rates of inappropriate shocks," said Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management for Boston Scientific.  "Recent data from a large number of patients from our ALTITUDE program show that nearly 98 percent were free of an inappropriate first shock within the first year of therapy when physicians chose to use AcuShock features in our COGNIS® and TELIGEN® devices."

About Boston Scientific

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: 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 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.

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