Guidant Enrolls First Patient in Japan Arm of
Drug Eluting Stent Trial
SPIRIT III U.S. Randomized Enrollment Passes Halfway Mark
INDIANAPOLIS, Dec. 13, 2005 -- Guidant Corporation (NYSE:GDT - News) today announced that the company has begun enrollment in the Japan arm of its SPIRIT III drug eluting stent clinical trial evaluating XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION® Coronary Stent System rapid exchange platform.
"We are pleased that patients and physicians in Japan have the opportunity to participate in this important drug eluting stent pivotal trial," said Dr. Shigeru Saito, director of Cardiology and Catheterization Laboratories, Shonan Kamakura Hospital, who enrolled the first patient in Japan and is the principal investigator for the Japan arm of the trial. "We are enthusiastic about the promise of the XIENCE V for the treatment of coronary artery disease, which impacts more than 2 million lives in Japan each year."
Guidant's SPIRIT III trial is one of the first to participate in Harmonization By Doing (HBD), an initiative to promote the convergence of regulatory requirements, processes and timelines between Japan and the United States. HBD represents international collaboration between Japan's Ministry of Health, Labour and Welfare / Pharmaceutical Medical Device Agency, the U.S. Food and Drug Administration (FDA), industry, clinical investigators, investigational sites and academia. Guidant's participation through piloting SPIRIT III will provide the opportunity to evaluate XIENCE V in both Japan and the United States concurrently in the same clinical trial, as opposed to conducting separate sequential trials in each country. The HBD program may set the stage for earlier introduction of XIENCE V into Japan.
"We are excited about the enrollment of our first patient in Japan, and pleased with our progress to date with SPIRIT III," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "In addition to recently passing the halfway mark in enrollment of the U.S. randomized portion, we have completed enrollment of 240 patients in the U.S. intravascular ultrasound (IVUS) cohort."
SPIRIT III Reaches Halfway Mark in U.S. Randomized Enrollment
SPIRIT III is a 1,380-patient clinical trial in the United States and Japan. The 1,002-patient randomized portion in the United States is a prospective, single-blind trial comparing XIENCE V versus the TAXUS® Express 2™ paclitaxel eluting coronary stent system for the treatment of coronary artery disease. The Japan arm of the trial is an 88-patient registry; the U.S. portion includes several registries.
SPIRIT III U.S. randomized enrollment has passed the halfway point, with more than 500 patients enrolled. Results of SPIRIT III are intended to support U.S. FDA approval of the XIENCE V Stent System and Ministry of Health and Welfare approval in Japan.
Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company 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 XIENCE™ V.
The statements are based on assumptions about many important factors, including
satisfactory enrollment and completion of the clinical trial, associated regulatory
processes and timelines, and other factors identified on Exhibit 99 to the company's
most recent filing on Form 10-Q. Actual results may differ materially. The company
does not undertake to update its forward-looking statements.
Source: Guidant Corporation |
