вторник, 3 мая 2011 г.

Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared To Bare Metal Stents In Randomized Clinical Trial

Clinical investigators at the
European Society of Cardiology Congress 2007 (ESC Congress 2007) reported that the CYPHER(R) Sirolimus eluting Coronary Stent continued to provide clinical benefits compared to a bare metal stent in the E-SIRIUS Trial out to five years of follow-up with no differences in safety.


At five-year follow-up, the patients in the CYPHER(R) Stent arm of the
study continued to be significantly less likely than the patients in the
bare metal stent arm to need another procedure in the same arterial area
(TLR or target lesion revascularization). In addition, the investigators
found similar rates of myocardial infarction (heart attack) and mortality
between the CYPHER(R) Stent and the bare metal stent, as well as no
significant difference between their rates of stent thrombosis (blood
clots).



"The five-year results of the E-SIRIUS Trial increase our knowledge and
understanding of the long-term clinical benefits of the CYPHER(R) Stent for
patients with coronary artery disease," said Erik Jorgensen, M.D., from The
Heart Centre, University Hospital Rigshospitalet, Copenhagen, Denmark, the
investigator who presented the results at the ESC Congress. "It is also
important to note that at five years, the long-term safety of the CYPHER(R)
Stent was comparable to the bare metal stent arm of this study, and this
reinforces the existing body of evidence supporting the long-term safety
and efficacy of the CYPHER(R) Stent."



The five-year results demonstrated that 5.1 percent of the patients in
the CYPHER(R) Stent arm underwent another procedure in the same arterial
area, compared to 20.9 percent of the patients in the bare metal stent arm
of the study. This means that a patient in whom a CYPHER(R) Stent was
implanted in this study was nearly 76 percent less likely to require a
second procedure in the same arterial area within five years than a patient
who was implanted a bare metal stent (p








"The results presented today reaffirm the long-term clinical benefits
of the CYPHER(R) Stent compared to bare metal stents," said David E.
Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis
Corporation. "As previously announced, Cordis is expanding the E-SIRIUS
Trial to eight years of follow-up to provide physicians with longer term
data about the CYPHER(R) Stent that will assist them in making informed
treatment decisions."



The E-SIRIUS trial is a double blind, multi-center, controlled,
randomized trial designed to compare restenosis (re-blockage) rates between
the CYPHER(R) Stent and a bare metal stent. It involved 352 patients from
35 European clinical centers. Patients enrolled in the study were
considered to be at a moderate to high clinical risk for restenosis due to
a previous heart attack or smoking.



The eight- and nine-month results of the E-SIRIUS Trial were published
in Lancet in October 2003. Cordis Corporation funded the E-SIRIUS Trial.



About the CYPHER(R) Stent



The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat
approximately three million patients with coronary artery disease. The
safety and efficacy of the device is supported by a robust clinical trial
program that includes more than 70 studies that examine the performance of
the CYPHER(R) Stent in a broad range of patients.



Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent
is currently available in more than 80 countries and has the broadest
clinical experience and longest-term clinical follow-up of any drug-eluting
stent. The next version of sirolimus-eluting stent, the CYPHER SELECT(TM)
Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific,
Latin America and Canada in 2003. The CYPHER SELECT(TM) Plus Stent, the
third version of a sirolimus-eluting coronary stent, received CE Mark in
2006 and is currently available in many markets outside the United States.



For more complete information on indications, contraindications,
warnings and precautions, see the Instructions for Use available at
cypherstent.



About Cordis Corporation



Cordis Corporation, a Johnson & Johnson company, is a worldwide leader
in the development and manufacture of interventional vascular technology.
Through the company's innovation, research and development, Cordis partners
with interventional cardiologists worldwide to treat millions of patients
who suffer from vascular disease. More information about Cordis Corporation
can be found at cordis.



(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Cordis' expectations and projections.
Risks and uncertainties 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. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of
this Form 10-K, as well as subsequent filings, are available online at
sec, jnj or on request from Johnson & Johnson. Cordis does
not undertake to update any forward-looking statements as a result of new
information or future events or developments.)



Cordis Corporation has entered into an exclusive worldwide license
with Wyeth for the localized delivery of sirolimus in certain fields of
use, including delivery via vascular stenting. Sirolimus, the active drug
released for the stent, is marketed by Wyeth Pharmaceuticals, a division of
Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth
Pharmaceuticals.


Cordis Corporation

cordis


View drug information on Rapamune.

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