According to Cordis, Nevo is the first and only drug-eluting stent utilizing a unique reservoir technology, which Cordis acquired from Conor Medsystems in 2007, and incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This design allows drug delivery from a stent with a surface that is 75% bare metal upon insertion and becomes fully bare metal following drug delivery and polymer bioresorption in approximately three months.
Nevo II will be a global, randomized, non-inferiority trial of approximately 2,000 patients with coronary artery disease. Results from this trial will provide long-term data in support of a pre-market application (PMA) with the FDA. The company plans to meet with regulatory authorities soon to finalize the design for this trial. Cordis, a Johnson & Johnson company, and Conor Medsystems, a developer of drug-eluting stents, are sponsors of this study.
In order to focus on realizing the full potential of Nevo, Cordis has said that it will cease development of the Cypher Elite sirolimus-eluting coronary stent program. Approximately 700 patients in the US have been enrolled in the clinical trial for this product and they will continue to be followed for five years, the duration of the follow-up period in the protocol. The data generated from this trial will contribute significantly to the company’s knowledge about sirolimus-eluting stents.
Campbell Rogers, chief scientific officer and global head, R&D at Cordis, said: “We continue to be very enthusiastic about Nevo and believe it represents the most significant advance in the drug-eluting stent market since we launched the Cypher stent.
“We also understand that in a rapidly evolving competitive and regulatory environment, 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.”