Cordis Corporation Announces Head-to-Head Randomized Clinical Trial Comparing the NEVO[TM] Sirolimus-Eluting Coronary Stent to the XIENCE[TM] Stent.BRIDGEWATER, N.J. -- Cordis Corporation, a worldwide leader in the field of interventional cardiology interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based , announced plans today to launch a global, head-to-head, randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. called NEVO NEVO New Evolution (Tallinn, Estonia) NEVO New Evolution in Home Control II which will compare the NEVO([TM]) Sirolimus-eluting Coronary Stent sirolimus-eluting coronary stent Cardiology A coronary artery stent graft which has sirolimus, an imunosuppressive and antimitotic agent incorporated into its matrix, which significantly ↓ restenosis of stents. See RAVEL. to the XIENCE V([TM]) Everolimus-eluting Coronary Stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent . Cordis Corporation and Conor Medsystems, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control are sponsors of the study. NEVO([TM]) is the first and only drug-eluting stent In cardiology, a drug-eluting stent is a stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation. This prevents scar-tissue–like growth that, together with clots (thrombus), could otherwise block the stented 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 1. bare metal - New computer hardware, unadorned with such snares and delusions as an operating system, an HLL, or even assembler. Commonly used in the phrase "programming on the bare metal", which refers to the arduous work of bit bashing needed to create these basic tools 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 See cipher. ([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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , non-inferiority trial of approximately 2,000 patients with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . Results from this trial will provide long-term data in support of a Pre-market Application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). 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 antiplatelet therapy Hematology Any therapy that inhibits platelet adhesion and/or aggregation, both of which ↑ complications of ASHD. See Aspirin, Thrombolytic 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. . 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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.) Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5917969&lang=en |
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