Clinical trial begins for innovative drug-eluting stent with unique reservoir technology
Warren, NJ – March 27, 2008– A randomized clinical trial comparing the Conor Sirolimus-eluting Coronary Stent, a new cobalt chromium reservoir-base stent design, to the Taxus Liberte Paclitaxel-eluting Coronary Stent has begun according to Conor Medsystems, LLC and Cordis Corporation, the sponsors of the study.
“We are pleased that the RES-ELUTION trial has begun and that the first patient enrolled in this study occurred at our hospital. The product was easily delivered and performed well,” said John Ormiston, M.D., North Shore Hospital, Auckland, New Zealand and Principal Investigator for this study. "The potential of sirolimus delivery from a fully-bioresorbable reservoir is exciting and may represent a breakthrough in the interventional treatment of patients with coronary artery disease."
The RES-ELUTION study is a randomized, multi-center comparison of the Conor Stent to the Taxus Liberte Stent in de Novo native coronary artery lesions. The primary endpoint of the study is angiographic in-stent late lumen loss at six months. The Conor Stent contains the Sirolimus-eluting Coronary®same drug, sirolimus, as in the CYPHER Stent, which is marketed by Cordis Corporation.
Secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. Up to 50 patients will also be evaluated via intravascular ultrasound (IVUS) at six months.
The study will involve 388 patients at 40 sites worldwide including Australia, Belgium, Brazil, Denmark, France, Germany, New Zealand, The Netherlands and the United Kingdom. Patients will receive clinical follow-up at 30 days, six months and annually through five years.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
The unique Conor Medsystems technology is an important ‘next generation’ technology design that incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This breakthrough design greatly enhances control of the rate and direction of drug delivery, enables a wider range of drug therapies, and potentially increases the range of clinical applications of drug-eluting stents and other drug-device combinations.
About Conor Medsystems, LLC
Conor Medsystems, LLC, a wholly-owned 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.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is 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.
(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 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 the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. 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. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

