The US-FDA in the latest “Updated Information for Physicians” on its Website for Center for Devices and Radiological Health (CDRH) has approved Cypher stent as safe and effective product when used according to the labeling.
Cypher is marketed by US-based Cordis Corporation. The FDA noted that Cordis had distributed more than 575,000 stents to date and that the number of reports of Sub-acute Thromboses or SAT associated with the stent were only 360. “Based on our review of data supporting the Cypher stent from clinical trials (some of which included treating more complex lesions), it appears that the rate of SATs is within the expected rate for any stent.”
Based on this, it concluded that SAT is a relatively rare event that occurs within the first 30 days following the stenting procedure and can occur with any stent, bare metal or a drug-eluting stent. The rate of sub-acute thrombosis associated with any stent is highly dependent on the population in which they are used. In this case, it noted, the stent had been used in a diverse population.