Guidant (NYSE:GDT)
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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.