The Circulatory System Devices Panel advising the US Food and Drug Administration (FDA) voted unanimously late on Tuesday to back the approval of Cordis Corporation’s Cypher sirolimus-eluting stent. Cordis is a unit of New Brunswick, New Jersey-based Johnson & Johnson.
Cypher is coated with the cytostatic drug to prevent restenosis within stented arteries due to neointimal hyperplasia and the formation of the fibrous scar tissue.
The FDA advisors primarily based their recommendations upon the results of a previously released study, in which use of the sirolimus-coated stent reduced the overall occurrence of restenosis by about 75% when compared with the bare metal stent. The study took place at 53 medical centers throughout the US and involved over 1,000 participants.
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