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New Long-Term Data Suggest Clinical Differences in Safety and Efficacy between CYPHER(R) Sirolimus-Eluting Coronary Stent and Taxus Stent.


Comparison Using 15-month Western Denmark Heart Registry Results Presented at TCT TCT The Capital Times (Madison, WI newspaper)
TCT Transcatheter Cardiovascular Therapeutics
TCT The Coroner's Toolkit
TCT Trans Canada Trail
TCT Tcl Core Team
TCT Tsukuba College of Technology (Japan) 
 2007

WASHINGTON -- An analysis of fifteen-month data from the Western Denmark Heart Registry found that patients who received the CYPHER See cipher. ([R]) Sirolimus-eluting Coronary Stent sirolimus-eluting coronary stent Cardiology A coronary artery stent graft which has sirolimus, an imunosuppressive and antimitotic agent incorporated into its matrix, which significantly ↓ restenosis of stents.
See RAVEL.
 had a lower risk of blood clots Blood Clots Definition

A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut.
 (stent thrombosis) and were less likely to need another procedure at the same lesion site (target lesion target lesion Dermatology A lesion typical of erythema multiforme–EM in which a vesicle is surrounded by an often hemorrhagic maculopapule; EM is often self-limited, of acute onset, resolves in 3-6 wks, and has a cyclical pattern; EM lesions are 'multiform'  revascularization) than patients who received a Taxus Stent. The study is being shown at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).

The differences between the CYPHER([R]) Stent and the Taxus Stent in terms of definite stent thrombosis, definite/probable/possible stent thrombosis and target lesion revascularization were statistically significant and favorable for the CYPHER([R]) Stent. Patients who received the Taxus Stent were 55 percent more likely to develop definite stent thrombosis than patients who received the CYPHER([R]) Stent (confidence interval confidence interval,
n a statistical device used to determine the range within which an acceptable datum would fall. Confidence intervals are usually expressed in percentages, typically 95% or 99%.
 (CI) 0.21-0.94). Taxus Stent patients were also 49 percent more likely to develop definite/probable/possible stent thrombosis than patients who received a CYPHER([R]) Stent (CI 0.30-0.87). In addition, the CYPHER([R]) Stent performed considerably better than the Taxus Stent in terms of target lesion revascularization, as Taxus Stent patients were 32 percent more likely to need a repeat procedure compared with patients who received the CYPHER([R]) Stent (CI 0.52-0.90).

"The study data show that the clinical outcomes following drug-eluting stent In cardiology, a drug-eluting stent is a stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation. This prevents scar-tissue–like growth that, together with clots (thrombus), could otherwise block the stented  implantation may depend on the type of stent used to treat a patient with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. ," said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.

"The CYPHER([R]) Stent continues to demonstrate excellent outcomes in clinical trials and in real-world settings," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "These findings are consistent with the results of other studies recently published in peer-reviewed medical journals (i.e. Stettler et al. Lancet 2007;370:937-48, Schomig et al. J Am Coll Cardiol 2007;50:1373-80, and Daemen et al. Lancet 2007;369:667-78) and build on the growing body of evidence indicating that the CYPHER([R]) Stent and the Taxus Stent should be evaluated separately."

The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who receive coronary angiograms or coronary interventions, including percutaneous interventions and bypass surgery Bypass surgery
A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis).
. This analysis evaluated patients from the registry who received a drug-eluting stent-- either the CYPHER([R]) Stent or Taxus Stent--from January 2002 through June 2005. Patients who received a combination of drug-eluting and bare metal 1. bare metal - New computer hardware, unadorned with such snares and delusions as an operating system, an HLL, or even assembler. Commonly used in the phrase "programming on the bare metal", which refers to the arduous work of bit bashing needed to create these basic tools  stents (BMS BMS
abbr.
Bachelor of Marine Science
) were excluded. All patients were followed for 15 months.

The primary endpoints of the study were stent thrombosis, myocardial infarction myocardial infarction: see under infarction.  and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.

Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram an·gi·o·gram
n.
An angiographic x-ray of blood vessels used in diagnosing pathological conditions of the cardiovascular system.//An x-ray of one or more blood vessels produced by angiography and used in diagnosing pathology in the cardiovascular
 at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.

About the CYPHER([R]) Stent

The CYPHER([R]) Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than 3 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.

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 a 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 www.cypherstent.com.

About Cordis Corporation

Cordis, 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.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 cost containment,
n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan.
. 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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 www.sec.gov, www.jnj.com 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.
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