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A global head to head trial of the Nevo sirolimus eluting and Xience everolimus eluting coronary stents is to be conducted by the Cordis Corporation.
Nevo is billed as the only drug eluting stent that incorporates hundreds of small reservoirs containing the same drug, Sirolimus, as the regular Cypher sirolimus-eluting stent used worldwide.
Says Cordis spokesman Campbell Rogers: “It is incumbent on companies to show how a new product compares to a more recently approved product in the category, which is what we are doing with this new trial.”
Nevo II will be a global, randomised, non-inferiority trial of 2,000 patients with coronary artery disease. Results will provide long term data to support a premarket application (PMA) with the US Food and Drug Administration (FDA). Cordis plans to meet with regulatory authorities soon to finalise the design for this trial.
In the US, the follow on Nevo III will be a pivotal trial for a PMA submission to the FDA, and will be a non-randomised, single-arm evaluation of clinical outcomes in approximately 1,000 patients.
Meanwhile, the six month trial results from Nevo I will be presented at the EuroPCR conference in Barcelona in May.
Copyright Press Association 2009