Healthcare Industry News: ARRIVE II registry
News Release - March 7, 2006
Boston Scientific to Release Broad Range of Clinical Study Results on Market-Leading Taxus(R) Coronary Stent System at ACC 2006Results highlight efficacy of TAXUS in most complex lesions and highest risk patients
NATICK, Mass., March 7 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced the schedule of the Company's major events at the annual American College of Cardiology Scientific Session, which runs from March 11 to 14 in Atlanta, Georgia.
"The data we will present at ACC from our TAXUS clinical studies demonstrates the performance of the TAXUS Express2 paclitaxel-eluting stent system as an effective treatment in the most complex lesions and highest risk patients, including diabetics," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "As the leader in drug-eluting stents, we continue to offer advanced deliverability and proven outcomes with our TAXUS stent systems. We expect our most recent clinical data will further reinforce that position."
Sunday, March 12 * TAXUS V ISR Results. At 10:00 a.m., the Company will release nine-month results from the TAXUS V In-Stent Restenosis (ISR) clinical trial, which evaluates the TAXUS Express2 paclitaxel-eluting coronary stent system versus vascular brachytherapy for the treatment of bare metal stent in-stent restenosis. The TAXUS V ISR trial is a prospective, randomized, open-label trial with a primary endpoint of target vessel revascularization (TVR) at nine months. The trial has enrolled 396 patients at 37 sites in the U.S. The results will be presented by Gregg W. Stone, M.D., the study's Principal Investigator, at a podium session in Hall C3 of the Georgia World Congress Center. The Company will also issue a press release at this time. The TAXUS V ISR results are scheduled to be published in the March 15 issue of The Journal of the American Medical Association (JAMA) with an advanced posting to its website on March 12 at http://jama.ama-assn.org.
* STENT Registry. At 9:40 a.m., nine-month results from the Strategic Transcatheter Evaluation of New Therapies (STENT) registry will be presented by Charles A. Simonton III, M.D., chairman of the executive steering committee for the STENT registry, at a podium session in Hall C3 of the Georgia World Congress Center. This large, independent, prospective, mulitcenter registry evaluates the comparative late clinical outcomes of paclitaxel- and sirolimus-eluting coronary stents among "real-world" cases and clinical situations, including diabetics and other high-risk patients. With a planned enrollment of more than 8,000 patients, the STENT registry is the largest study of its kind in the United States.
* DES Educational Symposium. From 8:00-10:00 p.m., the Company will host a symposium entitled, "Contemporary DES Data: A Clear Way to Put It All into Perspective" in the Grand Ballroom, North Tower of the Omni Hotel at the CNN Center. The symposium will be chaired by Stephen G. Ellis, M.D. and Patrick W. Serruys, M.D., Ph.D. The event will include case-based presentations and interactive sessions on the latest clinical evidence and "real-world" registry data for drug-eluting stents in complex patients. The Company will also host a reception prior to the symposium from 7:00 to 8:00 p.m. adjacent to the Grand Ballroom.
Monday, March 13 * Analyst Meeting. From 7:30-9:00 a.m., the Company will host an analyst meeting in the Grand Ballroom, North Tower of the Omni Hotel at the CNN Center. The meeting is open to the media. This meeting is being webcast and can be accessed at Boston Scientific's website, http://www.bostonscientific.com. Please visit the website for details on how to access the webcast. To ensure a timely connection to the webcast it is recommended that users register at least 15 minutes before the webcast begins. A replay of the webcast will be archived and available in the Webcast and Archives section of the Investor Relations site at http://www.bostonscientific.com.
Tuesday, March 14 * ARRIVE II registry data. The Company will release six-month results from its ARRIVE II registry, which has enrolled 5,007 consecutive patients at approximately 53 centers in the United States. The program is designed to collect and analyze "real-world" safety and clinical outcomes data from the TAXUS Express2 paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. The results will be presented by Malcolm Foster, M.D., an investigator for the study, from 10:00-11:00 a.m. at a poster session in Hall B1 of the Georgia World Congress Center. The Company will also issue a press release at this time.
Boston Scientific will present its latest innovations at booth #3446, including the new iLab Ultrasound Imaging System -- a completely functional IVUS system designed to be installed into a cath lab.
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.
CONTACT: Milan Kofol
Boston Scientific Corporation
Boston Scientific Corporation
Forward-Looking Statements This press release contains "forward-looking statements," including, among other statements, statements regarding the proposed business combination between Boston Scientific Corporation and Guidant Corporation, and the anticipated consequences and benefits of such transaction. Statements made in the future tense, and words such as "anticipate", "expect", "project", "believe", "plan", "estimate", "intend", "will", "may" and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Boston Scientific or Guidant. Relevant risks and uncertainties include those referenced in Boston Scientific's and Guidant's filings with the Securities and Exchange Commission ("SEC") (which can be obtained as described in "Additional Information" below), and include: general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. Risks and uncertainties relating to the proposed transaction include: required regulatory approvals will not be obtained in a timely manner, if at all; the proposed transaction will not be consummated; the anticipated benefits of the proposed transaction will not be realized; and the integration of Guidant's operations with Boston Scientific will be materially delayed or will be more costly or difficult than expected. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. Neither Boston Scientific nor Guidant assumes any obligation to update any forward-looking statements as a result of new information or future events or developments.
Boston Scientific and Guidant have filed a definitive prospectus/joint proxy statement with the SEC in connection with the proposed transaction. The material contained herein is not a substitute for the definitive prospectus/joint proxy statement or any other documents that Boston Scientific and Guidant have filed or will file with the SEC. Investors and security holders are urged to read the definitive prospectus/joint proxy statement and any other relevant documents filed or to be filed by Boston Scientific or Guidant, because they contain or will contain important information about the proposed transaction. The definitive prospectus/joint proxy statement is, and other documents filed or to be filed by Boston Scientific and Guidant with the SEC are or will be, available free of charge at the SEC's website (http://www.sec.gov) or from Boston Scientific by directing a request to Boston Scientific Corporation, One Boston Scientific Place, Natick, Massachusetts 01760-1537, Attention: Milan Kofol, Investor Relations, or from Guidant by directing a request to Guidant Corporation, 111 Monument Circle, 29th Floor, Indianapolis, Indiana 46204, Attention: Investor Relations.
Boston Scientific, Guidant and their respective directors, executive officers and other employees may be deemed to be participants in the solicitation of proxies from the security holders of Boston Scientific or Guidant in connection with the proposed transaction. Information about Boston Scientific's directors and executive officers is available in Boston Scientific's Annual Report on Form 10-K for the year ended December 31, 2005, and information about Guidant's directors and executive officers is available in Guidant's Annual Report on Form 10-K for the year ended December 31, 2005. Additional information about the interests of potential participants is included in the definitive prospectus/joint proxy statement referred to above.
Source: Boston Scientific
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