A small version of Cordis Corp.’s Cypher drug-eluting stent won approval from the Food & Drug Administration for treating blockages in small blood vessels.
The Bridgewater, N.J.-based Johnson & Johnson subsidiary said the federal watchdog’s approval of its 2.25mm Cypher sirolimus-eluting coronary stent was based on a quartet of studies comparing it to bare-metal stents.
Cordis touted data from several trials comparing 2.25mm Cypher with BSX’s Taxus Liberté Atom and Taxus Express Atom stents, which won FDA approval in May for treating small vessels.
Citing the ISAR-SMART 3 trial, Cordis said patients treated with its device showed 55 percent less “late loss,” or re-narrowing of the vessel as its walls grow around the stent, after eight months than patients receiving the Taxus.
And the company said data from the RESEARCH and T-SEARCH studies showed that patients treated with the small Cypher model had a 65 percent lower incidence of death or heart attack than patients treated with the 2.25mm Boston Scientific device.