Cordis files PMA for Cypher coronary stent

By Elaine Rigoli

Tampa, Fla., May 11 - Cordis Corp. filed a pre-market approval submission with the Food and Drug Administration for an in-stent restenosis indication for the Cypher sirolimus-eluting coronary stent. I In-stent restenosis is a reblockage of the coronary artery and a potential complication of stenting.

The foundation for the pre-market approval was data from the SISR trial, which showed that patients who received the Cypher stent had a significantly lower incidence of target vessel failure defined as cardiac death, heart attack or the need to re-open the artery (target vessel revascularization), compared with patients who received radiation from within a vessel (brachytherapy).

In this trial, Cordis said the Cypher stent was compared to brachytherapy for the treatment of blockage (restenosis) in patients who already have a bare-metal stent.

Cordis, a Johnson & Johnson company, develops and manufactures interventional vascular technology and is located in Miami Lakes, Fla.

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