Oct 8, 2001
Guidant and Cook Announce Submission of FDA filing to begin U.S. Drug-Coated Stent Trial

Indianapolis, Ind. and Bloomington, Ind. - Guidant Corporation (NYSE and PCX: GDT) and COOK Incorporated today announced that an investigational device exemption (IDE) application has been submitted to the U.S. Food and Drug Administration (FDA) to begin the DELIVER clinical trial for Cook's paclitaxel-coated stent, which will be distributed exclusively by Guidant. The new stent system, called ACHIEVE(tm), is manufactured by Cook and utilizes drug-coating technology developed by Cook, and stent and delivery system components supplied by Guidant to Cook.

The regulatory filing is based in part on the successful results of two important clinical studies conducted by Cook demonstrating preliminary safety and efficacy of paclitaxel-coated stents. The results of these studies were presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C.

"We look forward to beginning the clinical trial phase for the ACHIEVE stent," commented John Capek, Ph.D., president, Guidant vascular intervention. "We are pleased with the promising pre-clinical results experienced thus far with the ACHIEVE stent system, and in Cook's progress in manufacturing the stent systems that will be used in the clinical evaluation."

"Paclitaxel-coated coronary stents have already shown great promise in the treatment of coronary artery disease. Everyone at Cook is excited to begin the DELIVER trial, which we see as the next step in our strategic efforts to bring this important technology to heart disease patients in the United States in the most timely, efficient manner possible," noted John DeFord, Ph.D., president and chief executive officer of Cook.

As previously announced, Guidant and Cook signed a distribution agreement in which Guidant will be the exclusive worldwide distributor of the new stent, which will be developed and manufactured by Cook. As also previously announced, Guidant will manage the clinical trials and applicable regulatory submissions on behalf of Cook for this new product.

The ACHIEVE Stent utilizes paclitaxel, a drug that acts to prevent excessive cell re-growth (restenosis) at the site of the stent placement. Recent clinical studies suggest that paclitaxel-coated stents have a positive impact on restenosis.

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.