March 16, 2009 - Cordis Corp. said today it plans to launch a global, head-to-head, randomized clinical trial called NEVO II, which will compare the NEVO sirolimus-eluting coronary stent to the XIENCE V everolimus-eluting coronary stent.
Cordis and Conor Medsystems LLC are sponsors of the study.
NEVO is the first and only drug-eluting stent utilizing a unique reservoir (RES) technology, which Cordis acquired from Conor Medsystems in 2007. It incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This revolutionary design allows drug delivery from a stent with a surface that is 75 percent 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 sirolimus-eluting coronary stent, which has now been used in more than 3 million people worldwide. 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.
“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,” said Campbell Rogers, M.D., FACC, chief scientific officer and global head, research and development, Cordis. “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.”
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.
In the U.S., NEVO III will serve as the pivotal trial for a PMA submission to the FDA. NEVO III is designed as a non-randomized, 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 randomized trial compares NEVO to the TAXUS Stent and involves 394 patients. Results from this trial will support a design dossier submission for CE mark approval in Europe and in other countries that accept CE mark designation.
The previously announced NEVO RES II trial, a non-randomized, 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.
In other drug-eluting stent news from Cordis, the company announced plans to initiate a trial in the U.S. of approximately 2,000 patients that will compare clinical outcomes in a broad range of patients receiving dual antiplatelet therapy (DAPT) for 12 months versus 30 months after receiving a CYPHER stent. This trial will contribute to the company’s involvement in a broader DAPT clinical program that is being led by the FDA.
In order to focus on realizing the full potential of NEVO, Cordis noted that it will cease development of the CYPHER ELITE sirolimus-eluting coronary stent program. Approximately 700 patients in the U.S. 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.
For more information: www.cordis.com, www.res-technology.com