NATICK, Mass., Feb. 8, 2011 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today welcomed the publication of a sub-analysis of the MADIT-CRT trial data in the current issue of the Journal of American College of Cardiology that showed women received a greater clinical benefit from cardiac resynchronization therapy defibrillators (CRT-Ds) than men.
The sub-analysis demonstrated that both men and women experienced significant benefit from cardiac resynchronization therapy. However, women experienced a 70 percent reduction in heart failure events compared to a 35 percent reduction for men. Additional analysis demonstrated that women with asymptomatic or mild heart failure experienced a 72 percent reduction in all-cause mortality.
“CRT-D therapy has historically been underutilized in women compared to men with the same severity of heart disease,” said Kenneth Stein, M.D., Senior Vice President and Chief Medical Officer, CRM, for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “Boston Scientific believes that all patients, regardless of gender, should have equal access to high-quality cardiovascular care. We believe these findings will help draw attention to the benefits of CRT-D treatment for women, and therefore help reduce treatment disparities between women and men.”
A number of factors may have contributed to women experiencing a greater CRT-D benefit than men:
- MADIT-CRT found that Left Bundle Branch Block (LBBB) is an objective discriminator for a positive response to CRT and women in the trial were more likely than men to have LBBB.
- CRT-D therapy is designed to improve the heart’s overall pumping ability and women are more likely than men to have non-ischemic heart disease(1). Conversely, men are more likely to have ischemic heart disease (also known as coronary artery disease), which often leads to a more localized impact on heart function.
MADIT-CRT is the world’s largest randomized CRT-D study of New York Heart Association (NYHA) Class I and II patients(2), with more than 1,800 patients enrolled at 110 centers worldwide. Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine.
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 regulatory approvals, clinical trials and product performance. 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.