Label Affirms No Increased Heart Attack Risk

 

June 29, 2006

The FDA has approved revised labeling for the instructions for use of the CYPHER Sirolimus-eluting Coronary Stent. The labeling now reflects FDA's review of clinical trial data that suggests there is no increased risk of myocardial infarction with the use of overlapping CYPHER Stents in comparison to bare metal stents.

The change is based on a retrospective analysis of several clinical studies of overlapping CYPHER Stents examining more than 900 patients. Cypher is the only drug-eluting stent with this new label.

Overlapping stents are most often used in patients with complex coronary artery disease in which the blockage is too long for a single stent. Today, approximately 25 percent of stenting procedures involve the use of overlapping coronary stents.