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January 24, 2006 Categories: For professionals Posted by admin
The U.S. Food and Drug Administration (FDA) approved revised instructions for use (IFU) for the CYPHER(R) 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 (heart attack) with the use of overlapping CYPHER(R) Stents in comparison to bare metal stents. This labeling change is based on a retrospective analysis of several clinical studies of overlapping CYPHER(R) Stents examining more than 900 patients.
The CYPHER(R) Stent is the only drug-eluting stent with this new label.
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