Healthcare Industry News: Bare-Metal
News Release - March 8, 2006
Boston Scientific Submits Final Module for TAXUS(R) Liberte(TM) Coronary Stent System ApplicationNATICK, Mass., March 8 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of the Company's Pre-Market Approval (PMA) application for its TAXUS® Liberte(TM) paclitaxel-eluting coronary stent system. The TAXUS Liberte system is the Company's next-generation drug-eluting stent system. The third and final PMA module contains nine-month data from the ATLAS clinical trial, a global, multi-center, pivotal study designed to support FDA approval of the TAXUS Liberte system in the United States.
"Today's filing completes our application for FDA approval of the TAXUS Liberte coronary stent system and brings us a step closer to offering the first next-generation drug-eluting stent to patients in the U.S.," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "Since its launch last year in international markets, the TAXUS Liberte system has achieved a leadership position in virtually every market where it is sold. As the next generation to our market-leading TAXUS Express2(TM) system, the TAXUS Liberte system combines the proven benefits of our drug-eluting technology with excellent deliverability and conformability, particularly in challenging lesions."
Pre-Market Approval is the FDA process of scientific and regulatory review to evaluate the safety and efficacy of Class III medical devices prior to approval to market a device in the United States.
Boston Scientific launched its TAXUS Liberte stent system in select international markets in January 2005 and received the CE Mark in Europe in September 2005. In April 2005, the Company received U.S. FDA approval for its Liberte(TM) Bare-Metal coronary stent system.
The Company will announce nine-month data from its pivotal ATLAS clinical trial at the EuroPCR conference in May.
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.
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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.
Related News ItemsBoston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX(TM) LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option
Boston Scientific Announces Acquisition of Obsidio, Inc.
Boston Scientific Announces Agreement to Purchase Majority Stake of M.I.Tech Co., Ltd from Synergy Innovation Co., Ltd