Healthcare Industry News: NEVO RES I
News Release - March 16, 2009
Cordis Corporation Announces Head-to-Head Randomized Clinical Trial Comparing the NEVO Sirolimus-Eluting Coronary Stent to the XIENCE StentBRIDGEWATER, N.J.--(HSMN NewsFeed)--Cordis Corporation, a worldwide leader in the field of interventional cardiology, announced plans today to launch a global, head-to-head, randomized clinical trial called NEVO II which will compare the NEVO(TM) Sirolimus-eluting Coronary Stent to the XIENCE V(TM) Everolimus-eluting Coronary Stent. Cordis Corporation and Conor Medsystems, LLC are sponsors of the study. NEVO(TM) is the first and only drug-eluting stent utilizing 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 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(TM) contains the same drug, Sirolimus, as the CYPHER(R) Sirolimus-eluting Coronary Stent, which has now been used in more than three 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(TM) and believe it represents the most significant advance in the drug-eluting stent market since we launched the CYPHER(R) Stent,” said Campbell Rogers, M.D., F.A.C.C., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. “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 U.S. Food and Drug Administration (FDA). The company plans to meet with regulatory authorities soon to finalize the design for this trial.
In the United States, 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(TM) to the TAXUS(R) 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(R) 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(TM), Cordis noted that it will cease development of the CYPHER(R) ELITE(TM) 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. The data generated from this trial will contribute significantly to the company’s unmatched body of knowledge about Sirolimus-eluting stents.
“We believe NEVO(TM) is a significant step forward in stent technology,” said Dr. Rogers. “It marks a continuation of the Cordis tradition of innovation that began with our introductions of the first bare-metal stent and the first drug-eluting stent.”
About Conor Medsystems, LLC
Conor Medsystems, LLC, a subsidiary of Johnson & Johnson, develops innovative controlled vascular drug delivery technologies, and has primarily focused on the development of drug-eluting stents to treat coronary artery disease. For more information about RES Technology, visit www.res-technology.com.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
**The third party trademarks used herein are trademarks of their respective owners.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Cordis Corporation s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson s Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Cordis Corporation nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
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