Cordis announced on 16 March 2009 plans to launch a global, head-to-head, randomised clinical trial called NEVO II which will compare the Nevo Sirolimus-eluting Coronary Stent to the Xience V Everolimus-eluting Coronary Stent (Abbott). Cordis and Conor Medsystems, LCC are sponsors of the study.
Nevo is the first and only drug-eluting stent utilising a unique reservoir (RES) technology, which Cordis acquired from Conor Medsystems, LLC 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 contains the same drug, Sirolimus, as the Cypher, also from Cordis. The data supporting the safety and efficacy of sirolimus in coronary applications is now available out to six years, and this body of clinical evidence is completely unmatched by any other anti-restenotic stent coating.
NEVO II will be a global, randomised, 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 with the FDA. The company plans to meet with regulatory authorities soon to finalise the design for this trial.
In the USA, NEVO III will serve as the pivotal trial for a pre-market application submission to the FDA. NEVO III is designed as a non-randomised, single-arm trial evaluating clinical outcomes in approximately 1,000 patients.
The six-month trial results from NEVO RES I will be presented at the EuroPCR conference in Barcelona, Spain in May. This randomised trial compares Nevo to the Taxus Stent and involves 394 patients. Results from this trial will support a design dossier submission for CE mark.
The previously announced NEVO RES II trial, a non-randomised, single-arm registry of approximately 1,000 patients, has been canceled. The company will complete the protocol-defined follow-up for patients enrolled in this trial to date.