Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - September 30, 2010

CYPHER(R) Sirolimus Drug-Eluting Stent Remains Unsurpassed in Terms of Clinical Safety and Efficacy

SORT OUT IV Data Presented at TCT in Washington DC Shows Remarkable Clinical Safety and Efficacy Measures With Both CYPHER(R) Stent and XIENCE V(R) Stent

Only CYPHER Stent has More Than 10 years of Clinical Safety Data in 70 Studies


WATERLOO, Belgium, September 30, 2010 -- (Healthcare Sales & Marketing Network) -- Investigators reported results of SORT-OUT IV, comparing Cordis Corporation's CYPHER(R) Sirolimus-eluting Coronary Stent and Abbott's XIENCE V (R) Everolimus-eluting Stent in the primary endpoint of MACE (major acute coronary events) at nine months. These findings were presented the week commencing 20th September 2010 at the TCT Congress, one of the largest cardiovascular industry events held annually in Washington DC. This study adds to the unmatched body of clinical safety and efficacy data on the CYPHER(R) Stent with this comparison to the more recently approved XIENCE V(R) Stent in a contemporary setting.

"The SORT OUT consortium has used CYPHER(R) Stent as the comparator in a number of studies and to date, no newer stent has proven a benefit over CYPHER(R) Stent in terms of clinical safety or efficacy," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. "The clinical safety and efficacy of the CYPHER(R) Stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years."

The large randomized trial SORT OUT IV included more than 2,600 patients across a wide range of lesion and patient complexity. The study was designed to test whether the XIENCE V(R) stent is non-inferior to the CYPHER(R) Stent. Both drug-eluting stents performed better than planned for the composite endpoint of MACE (4.9 % for XIENCE V(R) Stent vs. 5.2% for CYPHER(R) Stent); these data support the non-inferiority of the XIENCE V(R) stent over the CYPHER(R) stent (non-inferiority p=0.01) . There was no statistically significant difference in key markers of safety including the incidence of cardiac death (1.9% for XIENCE V(R) Stent vs. 1.4% for CYPHER(R) Stent: p=0.31), myocardial infarction, (1.1% for XIENCE V(R) Stent vs. 1.4% for CYPHER(R) Stent: p=0.48), or definite or probable stent thrombosis (0.9% for XIENCE V(R) Stent vs. 0.9% for CYPHER(R) Stent: p=0.83).

"CYPHER remains an essential treatment option for today's interventional cardiologist considering its unsurpassed clinical safety and efficacy proven out to 10 years and the 7 extended indications (e.g. diabetes, AMI, multi vessel disease) in which CYPHER(R) stent specifically demonstrated superior outcomes," said Rogers.

Notes to Editors:

CYPHER(R) Sirolimus-eluting Coronary Stent in detail

The CYPHER(R) stent releases a unique anti-inflammatory and anti-proliferative-type medicine, sirolimus, into the artery wall over a period of 90 days. The sirolimus drug helps limit the overgrowth of normal cells while the artery heals. The CYPHER(R) Stent has a unique closed-cell design that allows the medicine to be distributed more evenly across the treated area and that helps to keep the arteries open and the blood flowing to the heart, reducing the chance of re-intervention in the treated area. Eighty percent (80%) of the sirolimus drug is released during the first 30 days. The rest is released by the end of 90 days.

About CYPHER(R) stent studies

The CYPHER(R) Stent is the most studied drug-eluting stent in the world, it has a proven safety profile out to 10 years and has been used in nearly 4 million patients worldwide. Today, with more than 9.000 citations on PubMed, CYPHER(R) Sirolimus-eluting Coronary Stent is recognized as having the most in depth clinical data, which marked it out as the most effective drug-eluting stent available today with a clinical safety profile presenting minimal risks. CYPHER's(R) body of clinical evidence is completely unmatched by any other drug-eluting stent. The CYPHER(R) Stent has consistently proven to control late loss across all vessel sizes and across a broad patient population, even in the most complex types of patients such as patients with diabetes and acute myocardial infarction. In fact, the CYPHER(R) Stent has shown more than 70% risk reduction in target lesion revascularization (TLR) when compared with bare metal stents.

About Cordis Corporation

For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been 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.

*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.

**The third party trademarks used herein are trademarks of their respective owners.


Source: Cordis

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