August 27, 2008 - Cordis Corp. today said it received CE mark approval to market the CYPHER SELECT Plus Sirolimus-eluting coronary stent for the treatment of acute myocardial infarction (AMI).
CE mark approval means 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, the company said. 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 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 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 vs. 14.3 percent for the BMS arm; (p
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., FACC, professor of cardiology, Assistance Publique-Paris University Hospitals, Paris, France, Cordis consultant 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.”
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 New England Journal of Medicine in September 2006.
CYPHER stents have been used in more than three million patients worldwide.
The CYPHER SELECT Plus Stent is not approved or available for sale in the U.S.
For more information: www.cordis.com