Healthcare Industry News: Boston Scientific
News Release - November 30, 2012
First Patient Enrolled in the Boston Scientific Multicenter Study of the SYNERGY(TM) Coronary Stent System Featuring a Bioabsorbable Polymer CoatingNATICK, Mass., Nov. 30, 2012 -- (Healthcare Sales & Marketing Network) -- The first patient has been enrolled in the Boston Scientific Corporation (BSX) EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the SYNERGY Stent System and support U.S. Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. Boston Scientific received CE Mark approval for the SYNERGY Stent System last month. The EVOLVE II clinical program is anticipated to enroll approximately two thousand patients at up to 160 sites worldwide including the United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore. The first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio. The SYNERGY Stent uses the market-leading everolimus drug and features an ultra-thin bioabsorbable polymer coating. The absorption of the polymer is completed shortly after drug elution ends at three months.
"SYNERGY is the most flexible, conformable and deliverable drug eluting stent platform that I have ever deployed," said Dean Kereiakes, M.D., F.A.C.C., Christ Hospital and the principal investigator of the study.
"I am enthusiastic about its potential impact on patient care since the SYNERGY System was designed to reduce the risk of late adverse events and the need for prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding, as well as increased cost."
The EVOLVE II clinical trial builds upon the EVOLVE study. EVOLVE was a prospective, randomized, single-blind, first human use study comparing the SYNERGY Stent to the PROMUS Element Stent, which uses a durable polymer coating. Outcomes with the SYNERGY Stent in EVOLVE were comparable to outcomes with the PROMUS Element Stent at six months and one year.
"We continue to strengthen our drug-eluting stent portfolio with innovations like the SYNERGY System in an effort to increase the advanced treatment options available to physicians and patients," said Kevin Ballinger, president of Interventional Cardiology at Boston Scientific. "This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader."
Patients enrolled in the EVOLVE II trial will be followed for five years. The SYNERGY Stent System is an investigational device in non-CE Mark countries and is not available for sale in the United States and Japan.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that 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, product performance and importance, and competitive offerings. 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.
Source: Boston Scientific
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