NATICK, Mass., April 24 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced completion of enrollment in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). The trial includes 1,820 patients and examines the potential benefits of Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) in a new population of heart failure patients. It is the latest in a series of landmark randomized clinical trials sponsored by Boston Scientific's Cardiac Rhythm Management group, following in the tradition of MADIT, MADIT II and COMPANION.
MADIT-CRT is designed to test whether CRT-Ds can slow the progression of heart failure in heart attack survivors and in those with other forms of impaired heart function. The trial may demonstrate if earlier intervention with CRT-D therapy can slow a patient's progression from early-stage heart failure (as defined by the New York Heart Association as Class I and II) to late-stage heart failure (Class III and IV).
"This study builds on the observations made in the COMPANION trial, which evaluated the benefits of CRT-D therapy in patients with late-stage, symptomatic heart failure," said Arthur Moss, M.D., Professor of Medicine at the University of Rochester, NY, and Principal Investigator of MADIT-CRT. "If positive, this trial may address the still unanswered question about the potential of resynchronization defibrillator therapy to inhibit the clinical progression of heart failure through earlier intervention."
"Boston Scientific is proud to sponsor MADIT-CRT, an important continuation of more than a decade of MADIT family trials," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This robust study design was created by leading cardiologists and is supported by medical science with appropriate endpoints to determine whether CRT-Ds can slow the progression of heart failure in Class I and II patients."
Approximately 70 percent of all heart failure patients fall into Class I or II. Nearly 22 million people worldwide, including approximately 5.5 million Americans, currently suffer from some form of heart failure. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.
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: http://www.bostonscientific.com.
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.
CONTACT: Paul Donovan
Boston Scientific Corporation
Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
Copyright©2008 PR Newswire.
All rights reserved