NATICK, Mass., Jan. 5 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has completed enrollment in its MAPS™ clinical trial, which is studying the coiling of intracranial aneurysms. This prospective, randomized trial commenced enrollment in 2007 and has reached its goal of 630 patients, enrolled at 47 hospitals in 11 countries. Principal investigators for the trial are Anil Gholkar, O.B.E., M.B.B.S., Clay Johnston, M.D., Ph.D., and Cameron McDougall, M.D.
The MAPS trial compares clinical outcomes in patients treated with either bare-platinum GDC® Detachable Coils or Matrix2® Detachable Coils, which are covered with a bio-polymer. The primary endpoint is Target Aneurysm Recurrence (TAR) at one year, a composite clinical endpoint of target aneurysm rupture or re-rupture, re-treatment or neurologic death. Secondary angiographic endpoints will be compared to the primary clinical outcomes over several years to evaluate the long-term predictive value of 12-month angiography.
"The MAPS trial has significant potential to enhance our understanding of the products we use to treat intracranial aneurysms as well as our methods for assessing outcomes," said Dr. Gholkar. "By conducting rigorous measurement, monitoring and adjudication of clinical outcomes over multiple years, the MAPS trial will establish a critical baseline from which to judge existing treatments as well as future endovascular technologies."
Aquilla Turk, D.O., is the Chairman of the MAPS Steering Committee and enrolled the final patient in the trial. "With enrollment completed, our focus now turns to data monitoring, completion of follow up and preparation for primary endpoint publication in 2011," said Dr. Turk. "The Steering Committee is grateful to all the trial investigators who have worked so diligently to reach this milestone."
"This important trial is the latest example of Boston Scientific's 24 years of collaboration and leadership in the field of neurointervention and lays the groundwork for continued advances in the minimally invasive treatment of brain aneurysms," said Mark Paul, President of Boston Scientific's Neurovascular business. "We appreciate the participation of the 124 physicians and 63 research coordinators, whose efforts led to the successful completion of enrollment."
For more information on the MAPS Trial visit: http://www.clinicaltrials.gov/ct2/show/NCT00396981.
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 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 clinical trials, regulatory approvals, clinical outcomes 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.
CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
Web site: http://www.bostonscientific.com/