Guidant to Temporarily Suspend XIENCE V Supply; Company Expects European Launch of XIENCE V in Third Quarter 2006
March 29 2006 - 7:00AM
Business Wire
Guidant Corporation (NYSE:GDT) today announced that a small
percentage (approximately 1 percent) of the current XIENCE V
inventory was not manufactured with strict adherence to its quality
standards. To maintain the highest level of quality assurance,
Guidant has decided not to release current XIENCE V inventory. As a
result, Guidant has voluntarily stopped enrolling new patients in
the 4.0 mm and the Japan arms of the non-randomized portion of its
SPIRIT III clinical trial. The trial is designed to evaluate the
safety and efficacy of Guidant's XIENCE(TM) V Everolimus Eluting
Coronary Stent System for the treatment of coronary artery disease.
Guidant plans to re-supply units to investigators as soon as new
inventory is available. The Company has already completed
enrollment of 1,002 patients in the randomized U.S. portion of the
trial, which was announced on March 15, 2006. John Capek, Ph.D.,
president, Vascular Intervention, Guidant Corporation, commented,
"Guidant is committed to providing the highest-quality products for
the treatment of heart disease. To ensure that the product meets
Guidant's quality standards, the Company will not utilize existing
inventories and will rebuild devices for SPIRIT III and the
upcoming European launch. This action will result in a charge of
approximately $15 million in the first quarter to write-off
existing XIENCE V inventory and will delay the European launch of
XIENCE V until the third quarter of 2006." The Company has notified
the U.S. Food and Drug Administration and the Chairman of the
SPIRIT III Data Safety Monitoring Board, as well as Boston
Scientific and Abbott of this temporary suspension. About SPIRIT
III Guidant's 1,380-patient SPIRIT III global clinical trial is
evaluating the XIENCE V Stent System in the United States and
Japan. Guidant received CE Mark approval of the XIENCE V in January
2006. Guidant Corporation pioneers lifesaving technology, giving an
opportunity for better life today to millions of cardiac and
vascular patients worldwide. The Company develops, manufactures and
markets a broad array of products and services that enable
less-invasive care for some of life's most threatening medical
conditions. For more information, visit www.guidant.com. This
release includes forward-looking statements concerning XIENCE V.
The statements are based on assumptions about many important
factors, including the timing of the availability of new inventory,
completion of the clinical trial, associated regulatory processes
and timelines, and other factors identified in the company's most
recent filing on Form 10-K. Actual results may differ materially.
The company does not undertake to update its forward-looking
statements. 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
(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.
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