Healthcare Industry News: Express2
News Release - March 16, 2010
Boston Scientific Completes Enrollment in PLATINUM Trials for Small Vessels and Long LesionsTrials to evaluate small vessel and long lesion versions of platinum chromium PROMUS(R) Element(TM) Stent System
NATICK, Mass., March 16 (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE:BSX ) today announced the completion of patient enrollment in the Small Vessel and Long Lesion trials of its PLATINUM clinical program. The trials are designed to compare the platinum chromium PROMUS® Element™ Everolimus-Eluting Stent System to matched historical control groups of patients treated with the TAXUS® Express2(TM) Paclitaxel-Eluting Stent System. The Small Vessel trial enrolled 94 patients with de novo lesions greater than or equal to 2.25 to less than 2.50 mm in diameter and less than or equal to 28 mm in length. The Long Lesion trial enrolled 102 patients with de novo lesions greater than 24 to less than or equal to 34 mm in length and greater than or equal to 2.50 to less than or equal to 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.
"Data from clinical studies have shown that small vessels and long lesions each represent an estimated 10 percent of percutaneous coronary interventions," said Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University/New York-Presbyterian Hospital and Principal Investigator for the PLATINUM program. "The availability of everolimus-based small vessel and long lesion stents will allow physicians greater flexibility in treating a broad range of complex coronary lesions. We look forward to the results of these important trials."
PLATINUM is a pivotal, randomized, controlled clinical trial program designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the PROMUS Element Stent. The Company received CE Mark approval for this product in October 2009. The PLATINUM Workhorse trial compares the PROMUS Element Stent to the PROMUS® Stent; it completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Results are expected to be presented in early 2011.
The PROMUS Element Stent is designed specifically for coronary stenting. The novel stent architecture and proprietary alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents(1).
"Boston Scientific has led the way in developing drug-eluting stents for small vessels and long lesions," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "The TAXUS® Express® Atom™ Stent and our more recent TAXUS® Liberte® Atom™ and TAXUS® Liberte® Long Stents have been adopted enthusiastically by our physician customers. The evaluation of a thin-strut, platinum chromium stent with a new drug offering reconfirms our commitment to providing the most complete range of solutions and sizes for physicians and their patients."
Boston Scientific stents have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up on TAXUS Stents to five years in some cases. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world's most frequently used stents.
In the U.S., the PROMUS Element Stent is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
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, competitive offerings, product performance and our market position. 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.
(1) Based on bench testing. Data on file with Boston Scientific.
Source: Boston Scientific
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