Mar 4, 2002
Guidant Completes Enrollment Of Paclitaxel Drug-Eluting Stent U.S. Trial

Clinical Trial Fully Enrolled In Less Than Four Months

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a global leader in cardiac and vascular technology, today announced that it has completed enrollment of 1,042 patients in the U.S. DELIVER Clinical Trial. The DELIVER trial is a single-blinded, randomized study comparing the paclitaxel-coated ACHIEVE(tm) Drug Eluting Coronary Stent to an uncoated bare-metal control stent. The study is designed to serve as the basis for Guidant's submission for U.S. Food and Drug Administration (FDA) approval of the ACHIEVE Stent System on behalf of Cook Incorporated. The new ACHIEVE Drug Eluting Coronary Stent System is manufactured by Cook Incorporated and will be distributed worldwide exclusively by Guidant.

"The enrollment of the DELIVER trial in less than four months is a clear demonstration of Guidant's capabilities within the clinical and regulatory arena and of Cook's ability to rapidly scale manufacturing to supply the necessary ACHIEVE stents for the clinical study," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "This milestone is further evidence of Guidant and Cook's swift progress in bringing this promising new therapy to patients with heart disease, and occurs just over six months since we announced our relationship with Cook on Aug. 21, 2001. We look forward to completion of the eight-month angiographic and nine-month clinical follow-up and rapid submission of the DELIVER clinical results to the FDA."

William O'Neill, M.D., director, Division of Cardiology and co-director, Beaumont Heart Center of William Beaumont Hospital in Royal Oak, Mich.; and William Knopf, M.D., of St. Joseph's Hospital in Atlanta, Ga., served as the principal investigators of the trial.

"This is a landmark study for cardiology, and could be a dramatic advancement for patients with heart disease,"" said Dr. O'Neill. "I am extremely enthusiastic about this new therapy."

"The DELIVER Trial was wholly supported by all the major medical centers that participated," said Dr. Knopf. "We are very encouraged and look forward to the results of the trial."

Prior clinical studies utilizing the proprietary paclitaxel drug-coating process developed by Cook have recently been reported. In Cook's ELUTES and ASPECT studies, a dose of paclitaxel similar to the one used in the DELIVER trial resulted in 3.1 percent and 4 percent restenosis rates, respectively. In these two studies, involving a total of 370 patients, paclitaxel was shown to reduce the incidence of restenosis at the site of the stent placement.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 10,000 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.