CYPHER SELECT Plus Sirolimus-eluting Stent Approved in the EU for Treatment of Diabetes Patients


February 16, 2009

February 16 - The CYPHER SELECT Plus Sirolimus-eluting Coronary Stent has received CE marking within the European Union (EU) for treatment of patients with diabetes, a complex and often difficult-to-treat patient population.

CE marking means conformity to the applicable European Directive and in the specific context of diabetes, permits the CYPHER SELECT Plus stent to be marketed for the treatment of diabetes in all member states of the EU.

The company said expanded indication for the CYPHER SELECT Plus is based on numerous clinical studies, both randomized clinical trials as well as nonrandomized trials that have been presented at major medical meetings and/or appeared in international peer reviewed publications, supporting the safety and efficacy of the device in patients with diabetes.

Patients with diabetes often present with challenging coronary anatomy. In addition to diabetes, CYPHER SELECT Plus has recently received CE marking for the following coronary conditions - chronic total occlusion, multi-vessel disease and bifurcations. In August 2008, CYPHER SELECT Plus received CE marking for treatment of acute myocardial infarction (heart attack). The stent was previously indicated for de novo lesions, in-stent restenosis and small vessels. CYPHER SELECT Plus now has a total of eight different indications.

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