NATICK, Mass., Oct. 5 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced its exclusive sponsorship and first enrollments of the MADIT-RIT clinical trial. This new trial follows in the tradition of three previous landmark trials: MADIT, MADIT II and MADIT-CRT, each exclusively sponsored by Boston Scientific and conducted under the leadership of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester.
MADIT-RIT is designed to determine which device programming strategy best minimizes the occurrence of unnecessary therapy in patients who have received an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) and have no history of cardiac arrest. Unnecessary therapy has a significant impact on quality of life, especially for patients with no history of cardiac arrest.
The MADIT-RIT trial is a prospective, randomized study that will enroll 1,500 patients at approximately 75 centers globally.
"Clinical science has proved time and again that ICDs are highly effective in reducing death due to arrhythmias in high-risk cardiac patients," said Dr. Moss. "However, some patients receive unnecessary therapy, partly due to the programming of these devices at implant. MADIT-RIT will study the effects of programming on the occurrence of unnecessary therapy in these patients."
The first enrollments in this worldwide trial occurred last month in Graz, Austria at the Medizinische Universitatsklinik Graz (Burkert M. Pieske, M.D., and Daniel Scherr, M.D.); Basel, Switzerland at the Universitatsspital Basel (Beat Schaer, M.D., and Christian Sticherling, M.D.); Detroit, Michigan at the St. John Hospital and Medical Center (Luis Pires, M.D.); and Little Rock, Arkansas at Arkansas Cardiology (Steven Greer, M.D.).
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 trial outcomes and regulatory approval of our products. 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.
Boston Scientific Corporation
CONTACT: Paul Donovan, Media Relations, +1-508-650-8541 (office),
+1-508-667-5165 (mobile); David Knutson, Media Relations, +1-651-260-8288
(mobile); or Larry Neumann, Investor Relations, +1-508-650-8696 (office), all
of Boston Scientific Corporation
Web Site: http://www.bostonscientific.com/
