Johnson & Johnson subsidiary Cordis, has launched a global, head-to-head, randomized clinical trial to compare its Nevo sirolimus-eluting coronary stent with the Xience V everolimus-eluting coronary stent from Abbott.
Nevo is a drug-eluting stent utilizing reservoir (RES) technology, which Cordis acquired from Conor Medsystems in 2007. RES technology incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded, according to the Bridgewater, N.J.-based Cordis. The design allows a stent with a surface that is 75 percent bare metal upon insertion to become fully bare metal following drug delivery and polymer bio-resorption in approximately three months.
Cordis said NEVO II will be a global, randomized, non-inferiority trial of approximately 2,000 patients with coronary artery disease. The company said it hopes the results will provide long-term data in support of a pre-market application with the FDA; it plans to meet with regulatory authorities soon to finalize the design for the trial.
Cordis and the Menlo Park, Calif.-based Conor Medsystems are co-sponsors of the study.