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 European Union.
The expanded indication for the CYPHER SELECT®Plus Stent is based on numerous clinical studies, both randomized clinical trials as well as non-randomized 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.
“It is well documented that patients with diabetes have a high risk of complex coronary artery disease,” said Campbell Rogers, M.D., Chief Scientific Officer, Cordis Corporation. “Today’s announcement provides diabetic patients and their physicians with critical validation of an important treatment tool.”
Patients with diabetes often present with challenging coronary anatomy. In addition to diabetes, CYPHER SELECT®Plus Stent 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). CYPHER SELECT® Plus Stent was previously indicated for de novo lesions, in stent restenosis and small vessels. CYPHER SELECT® Plus has a total of eight different indications.
Dr. Rogers added, “When taken collectively, diabetes, heart attack, multi-vessel disease, chronic total occlusions and bifurcations, represent the most challenging coronary conditions we see today. It is an important step forward for patient care that the CYPHER SELECT® Plus Stent is now indicated for these complex conditions.”
Source: Johnson & Johnson
published: February 17, 2009 in: Cardio, Companies, Products, Regulatory, Specialty