Boston Scientific
Corporation (NYSE: BSX) today welcomed an article in the Journal of the
American Medical Association (JAMA) on the TAXUS V ISR (in-stent restenosis)
clinical trial that found the TAXUS(R) Express2(TM) paclitaxel-eluting stent
system achieved superior outcomes in the treatment of in-stent restenosis
compared to those patients treated with radiation-based brachytherapy. The
results of the study were published in today's edition of JAMA.
The study (TAXUS V ISR) showed that compared with brachytherapy,
implantation of paclitaxel-eluting stents reduced the nine-month rate of
target vessel revascularization (the need for a repeat procedure in the
stented area) from 17.5 percent to 10.5 percent and target lesion
revascularization rate from 13.9 percent to 6.3 percent. The study also
demonstrated an 11.5 percent rate of Major Adverse Cardiac Events (MACE) for
the TAXUS stent group, as compared to a 20.1 percent rate for the control
group.
"The results from this trial in concert with other studies, indicate that
drug-eluting stents should now be considered the treatment of choice for most
patients with ISR of previously implanted bare-metal stents. Paclitaxel-
eluting stents significantly reduce clinical and angiographic restenosis and
improve event-free survival compared with beta-source intracoronary radiation.
For patients with bare-metal stents who develop in-stent restenosis, the
availability of drug-eluting stents represents a safe therapy resulting in a
high rate of nine-month event-free survival, a reassuring option for an
otherwise difficult-to-treat cohort of patients. Further studies are required
to demonstrate the long-term safety and durability of this approach," the
authors conclude.
The study included 396 patients at 37 sites in the United States and was
designed to assess the TAXUS stent slow-release formulation paclitaxel-eluting
coronary stent system in reducing in-stent restenosis (the regrowth of
diseased tissue into a previously stented artery) versus intracoronary
brachytherapy (radiation delivered directly to the lesion). An additional 25
patients were enrolled in a registry arm. It had a primary endpoint of nine-
month target vessel revascularization.
CAUTION - The TAXUS(R) Express2(TM) paclitaxel-eluting stent system is
considered investigational in the United States for use in treating in-stent
restenosis and for this indication is limited by Federal Law to
investigational use only.
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties.
This press release contains forward-looking statements. The Company
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, risks associated with clinical
trials, the regulatory approval process, commercialization of new
technologies, intellectual property, and other factors described in the
Company's filings with the Securities and Exchange Commission.
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.
Additional Information
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
(sec) 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.
Boston Scientific Corporation
bostonscientific
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