Cordis has received CE mark approval to market its Cypher Select Plus sirolimus-eluting coronary stent for the treatment of acute MI, so it can now be promoted in all member states of the European Union (EU), European Economic Area and Switzerland.
The Warren, N.J.-based company said its expanded indication for the Cypher Select Plus stent in the EU is based on several scientific publications, including data from TYPHOON (Trial to Assess the use of the CYPHER stent in Acute MI Treated with Balloon Angioplasty), a randomized, multi-center clinical trial to study the safety and efficacy of the Cypher stent in patients who suffered a heart attack.
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 scientific sessions in March 2006 and the data also appeared in the New England Journal of Medicine in September 2006.
The Cypher Select Plus stent is not approved or available for sale in the U.S.