Cordis, a developer of interventional vascular technology, has received approval from the FDA for a new, smaller (2.25 mm) version of its Cypher sirolimus drug-eluting coronary stent.
The Bridgewater, N.J.-based company said the approval is based on the results of four studies including, in part, the clinical results of the SES-SMART trial. The trial randomly compared the 2.25 mm Cypher stent to bare-metal stents in the reduction of restenosis in small coronary arteries. At two years, patients receiving the Cypher stent had an 82 percent reduction in restenosis compared with a bare-metal stent at six months.
Earlier this year, the FDA approved two other drug-eluting stents for the treatment of small vessel disease, Boston Scientific’s Taxus Liberte Atom stent and Taxus Express Atom stent, both of which elute paclitaxel.