CYPHER SELECT® Plus Sirolimus-eluting Coronary Stent Receives CE Mark Approval for Treatment of Heart Attacks
Cordis Corporation today announced that it has received CE mark approval to market the CYPHER SELECT® Plus Sirolimus-eluting Coronary Stent for the treatment of acute myocardial infarction (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 and Switzerland.
The expanded indication for the CYPHER SELECT® 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 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 CYPHER SELECT® 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® Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty), the first randomized, multi-center clinical trial to study the safety and efficacy of the CYPHER® Stent in patients who suffered a heart attack.
In TYPHOON, the CYPHER® Stent reduced the risk of target vessel failure (TVF) 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® 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® 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® 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 annual scientific session in March 2006 and the data also appeared in the prestigious New England Journal of Medicine in September 2006.
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