Nov 12, 2001
Guidant Commends Cook on Promising Results of Latest Paclitaxel-Coated Stent Trial

Indianapolis, Ind. and Anaheim, Calif. - Guidant Corporation (NYSE and PCX: GDT) congratulated Cook Incorporated on the announcement of Cook's highly positive results from its paclitaxel-coated stent trial, reported yesterday at the 74th Annual Scientific Sessions of the American Heart Association.

"Cook's results are very promising and we commend their research team on the results of this trial," said John Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The knowledge gained in this trial will be valuable as we continue our collaboration with Cook. This collaboration, coupled with the rapid progress we have made on our internal PHARMA-LINK(tm) Drug Coated Stent Program utilizing Actinomycin-D, demonstrates our commitment to bring this promising therapy to patients as quickly as possible."

The results announced by Cook were from its 192-patient ELUTES (EvaLUation of pacliTaxel-Eluting Stent) Trial, which served, in part, as the basis for Guidant's submission for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for its DELIVER trial. The DELIVER trial, which began enrollment on Nov. 9, will serve as the basis for Guidant's submission for FDA approval of the ACHIEVE(tm) Paclitaxel Coated Stent System.

In August, Guidant and Cook signed a distribution agreement in which Guidant will be the exclusive worldwide distributor of the new ACHIEVE stent system, which will be developed and manufactured by Cook. As part of that agreement, Guidant will manage the clinical trials and applicable regulatory submissions on behalf of Cook for this new product.

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.