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CYPHER SELECT(R) Plus Sirolimus-eluting Coronary Stent Receives CE Mark Approval for Treatment of Heart Attacks.


WARREN, N.J. -- Cordis Corporation today announced that it has received CE mark approval to market the CYPHER SELECT([R]) Plus 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.
 for the treatment of acute myocardial infarction acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē·  (AMI), more commonly known as a heart attack. CE mark approval means that the product has been deemed safe and effective for treatment of AMI and can now be promoted for this indication in all Member States of the European Union (EU), European Economic Area European Economic Area: see European Free Trade Association; European Union.  and Switzerland.

The expanded indication for the CYPHER SELECT([R]) Plus Stent provides physicians with another option for treating this serious cardiac event. According to Working Group on Interventional Cardiology of the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe.  and European Association of Percutaneous Cardiovascular Interventions, more than 150,000 percutaneous coronary interventions are performed for heart attacks every year in Europe. (EuroIntervention; 2007; 3: 442-446).

The expanded indication for the CYPHERSELECT([R]) Plus Stent in the EU is based on several scientific publications providing clinical evidence for this indication, especially data from TYPHOON (Trial to Assess the use of the CYPHER([R]) Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty), the first randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, multi-center clinical trial to study the safety and efficacy of the CYPHER([R])Stent in patients who suffered a heart attack.

In TYPHOON, the CYPHER([R]) Stent reduced the risk of target vessel failure (TVF TVF Target Vessel Failure (cardiology)
TVF Time Variant Filter
TVF Thief River Falls, MN, USA - Thief River Falls Municipal (Airport Code)
TVF Tactile Vocal Fremitus
TVF Turkiye Voleybol Federasyonu
) by almost half in patients who suffered a heart attack compared to those who were treated with a bare metal stent (BMS) (7.3 percent for the CYPHER([R])Stent vs. 14.3 percent for the BMS arm; (p<0.004). TVF is a composite of the need for re-treatment (target vessel revascularization or TVR), recurrent heart attack, and death due to cardiac reasons.

In addition, the overall mortality rate in both the CYPHER([R])Stent arm of the trial and the BMS arm was low (2.2 percent in both).

"No other drug-eluting stent has this level of clinical data support in the setting of primary angioplasty for acute myocardial infarction," said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris University Hospitals, Paris, France and lead author of the TYPHOON study.

"More than 3,000 patients have been included in nine randomized trials to assess the safety and efficacy of the CYPHER SELECT([R]) Plus Stent in AMI. All of these studies have demonstrated significant reductions in the occurrence of repeat revascularization at one year with no increase in stent thrombosis, death or repeat myocardial infarction. Long-term follow-up has also demonstrated that these results are sustained," he said. Dr. Spaulding receives consulting and lecture fees from Cordis Corporation.

The TYPHOON trial was conducted at 48 sites across Europe, Israel and Australia. Clinical trial data were initially presented at the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S.  annual scientific session in March 2006 and the data also appeared in the prestigious New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world.  in September 2006.

About the CYPHER SELECT([R]) Plus Stent

Featuring an enhanced stent delivery system, the CYPHER SELECT([R]) Plus Stent offers exceptional deliverability, as well as the excellent, long-term clinical performance for which the CYPHER([R])Stent is widely known.

The CYPHER SELECT([R]) Plus Stent is not approved or available for sale in the United States.

In addition to its flexible stent design and short tip, CYPHER SELECT([R]) Plus Stent features the CYPH CYPH Cyclophilin 2ONIC ONIC Oman National Investment Corporation
ONIC Office National Inter-Professionnel des Céréales
[TM] Hydrophilic hydrophilic /hy·dro·phil·ic/ (-fil´ik) readily absorbing moisture; hygroscopic; having strongly polar groups that readily interact with water.

hy·dro·phil·ic
adj.
 Coating Technology, an innovative coating technology that is significantly more lubricious lu·bri·cious   also lu·bri·cous
adj.
1. Having a slippery or smooth quality.

2. Shifty or tricky.

3.
a. Lewd; wanton.

b. Sexually stimulating; salacious.
 than previous CYPHER([R])Stent products, greatly increasing a physician's ability to successfully navigate challenging coronary arteries.

CYPHER([R]) Stents have been used in more than three million patients worldwide.

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.

(a)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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Date:Aug 27, 2008
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