Guidant Completes Enrollment in International
Drug Eluting Stent Clinical
Trial
Data from Study Will Support Launch of XIENCE V Coronary Stent System Outside the United States
INDIANAPOLIS, Ind. & BRUSSELS, Belgium, Nov. 10, 2005 -- Guidant Corporation (NYSE:GDT - News) today announced that the company has completed enrollment in its SPIRIT II drug eluting stent clinical trial.
SPIRIT II is a 300-patient randomized clinical trial evaluating XIENCE™ V,
an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium
rapid-exchange MULTI-LINK VISION® Coronary Stent System platform. This single-blind,
prospective, randomized, non-inferiority study further evaluates the XIENCE V
compared to the TAXUS® Express 2™ paclitaxel eluting coronary stent system
for the treatment of coronary artery disease. Results of the SPIRIT II study
will provide additional clinical data to support the launch of XIENCE V in several
countries outside the United States. The primary endpoint of the trial is in-stent
late loss at six months.
"SPIRIT II will provide additional important data about the combination of everolimus and our most advanced coronary stent system, the MULTI-LINK VISION Coronary Stent System, for the treatment of coronary artery disease in a more challenging patient population," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant. "SPIRIT II completed enrollment in just four months, an achievement that illustrates the capabilities of Guidant's clinical organization and the dedication of the investigators from Europe, India, South Africa and New Zealand to the XIENCE V program and to the SPIRIT II trial under the valued leadership of Prof. Patrick Serruys."
Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, serves as the trial's principal investigator. "The SPIRIT II trial will continue to evaluate the clinical experience of XIENCE V, which demonstrated excellent six-month results in the SPIRIT FIRST trial reported last fall," said Prof. Serruys. "We look forward to the presentation of additional results from SPIRIT FIRST at the American Heart Association Scientific Sessions next week."
SPIRIT III is a 1,380-patient global clinical trial evaluating the XIENCE V Stent System 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. To date the randomized U.S. trial has enrolled approximately 400 patients. Results of SPIRIT III are intended to support U.S. Food and Drug Administration (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.
Contact:
Steven Tragash, Corporate Communications, 317-971-2031
Doug Hughes, Investor Relations, 317-971-2039
Source: Guidant Corporation |
