Nov 19, 2003
Guidant Provides Overview of Drug Eluting Stent Program
Company Reiterates 2005 Introduction of First Drug Eluting Stent
New York - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today is providing a comprehensive overview of the company''s progress in its drug eluting stent program at Guidant''s annual Investor/Analyst Conference in New York City.
During the conference, Dana G. Mead, Jr., president, Vascular Intervention, Guidant, is outlining a clinical path to market for Guidant''s first everolimus eluting stent, the CHAMPION(tm) Drug Eluting Stent System. Mead is announcing that:
- Guidant recently filed with European regulatory authorities the second module of the application to support the CHAMPION Drug Eluting Stent System Conformité Européenne (CE) Mark approval.
- In early 2004 the company plans to initiate FUTURE III, an 800-patient clinical trial that will provide additional safety and performance data to support market launch of the CHAMPION Drug Eluting Stent System outside of the U.S.
- In collaboration with the U.S. Food and Drug Administration (FDA), Guidant has finalized its clinical trial strategy and plans to move forward with FUTURE IV, a 975-patient U.S. pivotal trial for the CHAMPION Drug Eluting Stent System, slated to begin in the first half of 2004.
- Guidant expects to launch the CHAMPION Drug Eluting Stent System in Europe in the first quarter of 2005 and in the United States in the first quarter of 2006.
In addition, Mead is sharing plans for next-generation everolimus eluting stent products, which will be based on the cobalt chromium MULTI-LINK VISION(tm) Coronary Stent System. He is also announcing that a MULTI-LINK VISION-based everolimus eluting stent system with a durable polymer will be evaluated in the company''s SPIRIT FIRST European feasibility trial, which is expected to commence by early next year. Guidant anticipates introducing a cobalt chromium-based drug eluting stent system in the United States in late 2006.
"The strategy we are outlining today provides additional clarity as to our regulatory and clinical plan as we prepare to market drug eluting stents," said Mead. "We have achieved key clinical milestones and significantly enhanced our capabilities and, based on the everolimus data we have seen to date and the stent system''s acute performance, we have great confidence that the CHAMPION Stent System will be a highly competitive product."
Campbell D. K. Rogers, M.D., director, Cardiac Catheterization Laboratory and assistant professor of Medicine, Brigham and Women''s Hospital, is providing a detailed review of the CHAMPION Drug Eluting Stent System''s technology and is presenting the clinical trial strategy for the product.
"The FUTURE I and FUTURE II trials support safety and efficacy of an everolimus eluting stent, with clinical data that appears to be durable at 12 months," said Dr. Rogers. "The FUTURE III and FUTURE IV clinical trials constitute a focused approach that should facilitate timely market introductions."
Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.
This release includes forward-looking statements concerning development timelines for and the competitiveness of the company''s drug eluting stents. The statements are based on assumptions about many important factors, including regulatory timelines, satisfactory clinical results, other clinical factors, such as speed of trial enrollment, any litigation or competitive developments, and other factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.