New MADIT II Clinical Data Analysis Shows Long-Term Survival Benefit For Implantable Defibrillator Therapy

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 15 May 2009 - 1:00 PDT

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Boston Scientific Corporation (NYSE: BSX) announced that an analysis of long-term data from the MADIT II clinical study demonstrates that the life-saving benefits of implantable cardioverter defibrillator (ICD) therapy remain sustainable at eight years. This is the first time long-term data have been presented regarding the life-saving benefits of ICDs in a primary prevention population. The analysis was presented during a late-breaking session at the Heart Rhythm Society Scientific Sessions in Boston.

The analysis shows a sustainable mortality benefit over time, including:

-- At eight years, one life is saved for every six patients who receive an ICD. This represents a significant improvement over the two-year MADIT II data, which showed one life saved for every 17 patients.

-- A 41 percent relative reduction in the risk of death for ICD patients at four years

-- A 37 percent relative reduction in the risk of death for ICD patients at eight years

The MADIT II study, sponsored exclusively by Boston Scientific, was designed to determine whether ICDs improve survival when compared to drug therapy alone in heart attack survivors with moderate impairment of the left ventricle, the heart's main pumping chamber. Initial results published in the New England Journal of Medicine (March 21, 2002) demonstrated that ICD therapy reduced the relative risk of death by 31 percent at 20 months follow-up.

"ICD therapy has proved effective in patients at risk of sudden cardiac death, and now the long-term MADIT II data show the life-saving benefits of these devices continue over time," said Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center and Principal Investigator of the MADIT, MADIT II and MADIT-CRT trials.

"We are proud to have been the exclusive sponsor of landmark trials like MADIT II," said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. "More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this life-saving therapy through Boston Scientific clinical research."(1)

Cautionary Statement Regarding Forward-Looking Statements

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 our product performance, clinical outcomes, regulatory approval of our products, and our growth strategy. 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.

(1) Trials include MADIT, MADIT II, CONTAK-CD, and COMPANION.

Source: Boston Scientific Corporation