Cordis to Study Nevo DES in Global Clinical Trial

March 16, 2009—Cordis Corporation (Warren, NJ) announced plans to launch the NEVO II global, head-to-head, randomized clinical trial that will compare the company's Nevo sirolimus-eluting coronary stent to the Xience V everolimus-eluting coronary stent (Abbott Vascular, Santa Clara, CA). The study is sponsored by Cordis Corporation and Conor Medsystems, LLC (Menlo Park, CA), which was acquired by Cordis in 2007.

According to Cordis, Nevo utilizes Conor's RES reservoir technology that 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 after drug delivery and polymer bioresorption in approximately 3 months.

NEVO II will be a global, randomized, noninferiority trial of approximately 2,000 patients with coronary artery disease. Results from this trial will provide long-term data in support of a premarket application with the US Food and Drug Administration (FDA). The company plans to meet with regulatory authorities soon to finalize the design for this trial. In the US, NEVO III will serve as the pivotal trial for a premarket application submission to the FDA. NEVO III is designed as a nonrandomized, single-arm trial evaluating clinical outcomes in approximately 1,000 patients.

Cordis stated that the 6-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 (Boston Scientific Corporation, Natick, MA) in 394 patients. Results from this trial will support a submission for CE Mark approval.

The previously announced NEVO RES II trial, a nonrandomized, single-arm registry of approximately 1,000 patients, has been cancelled. The company will complete the protocol-defined follow-up for patients enrolled in this trial to date.

Cordis advised that it will cease development of the Cypher Elite sirolimus-eluting coronary stent program in order to focus on developing the Nevo stent.

Approximately 700 patients in the United States have been enrolled in the clinical trial for the Cypher Elite. They will continue to be followed for 5 years, the duration of the follow-up period in the protocol. The data generated from this trial will contribute significantly to the company's body of knowledge about sirolimus-eluting stents.

In other company news, Cordis announced plans to initiate a trial in the United States of approximately 2,000 patients that will compare clinical outcomes in a broad range of patients receiving dual-antiplatelet therapy for 12 months versus 30 months after receiving a Cypher stent. This trial will contribute to the company's involvement in a broader dual-antiplatelet therapy clinical program that is being led by the FDA.