Johnson and Johnson reports CE Mark for Cypher Select Plus stent

Cordis, a Johnson & Johnson company, has announced its Cypher Select Plus sirolimus-eluting coronary stent has received CE Mark approval for the treatment of acute myocardial infarction, or heart attack.

The stent can now be marketed in all European Union member states, in addition to the European Economic Area and Switzerland.

Expanded indication for the Cypher Select Plus is based on a number of scientific publications, including data from the Typhoon rial, the first randomised and multi-centre clinical study to assess the efficacy and safety of the stent in heart attack patients.

In the study, the Cypher Select Plus reduced the risk of target vessel failure by almost half in heart attack patients compared to those treated with a bare metal stent.

Christian Spaulding, professor of cardiology at the Assistance Publique-Paris University Hospitals, said: “No other drug-eluting stent has this level of clinical data support in the setting of primary angioplasty for acute myocardial infarction.”

He added over 3,000 patients have been treated over nine randomised trial to assess the efficacy and safety of the stent, with all showing a significant reduction in the incidence of repeated revasularisation at one year with no stent thrombosis.

In October 2007, Cordis presented new data showing the introduction of drug-eluting stents can offer improved clinical outcomes while reducing healthcare costs.