Guidant Announces Filing for European Approval to Market Drug Eluting Stent; ACHIEVE CE Mark Filing Represents Milestone in Guidant's Drug Eluting Stent Efforts

Business Wire, Feb 1, 2002

Business & Health/Medical Editors

INDIANAPOLIS--(BW HealthWire)--Feb. 1, 2002

Guidant Corporation (NYSE:GDT) (PCX:GDT) today announced that the company has filed for CE Mark approval to market the ACHIEVE(TM) drug eluting paclitaxel-coated coronary stent in Europe. The new stent system will be manufactured by Cook Incorporated and utilizes drug-coating technology developed by Cook, and stent and delivery system components supplied by Guidant to Cook. Paclitaxel 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 the prevention of restenosis.

"This filing is a significant milestone for Guidant's drug eluting stent efforts," said John Capek, Ph.D., president, Vascular Intervention, Guidant. "We are pleased to be among the first companies worldwide to bring this promising new therapy to market for the treatment of coronary artery disease."

Additionally, Guidant's internal PHARMA-LINK(TM) Drug Eluting Stent Program continues to make very good progress. Thirty-day follow-up in Guidant's ACTION clinical trial utilizing Actinomycin D has revealed no safety concerns. Guidant is now in the six-month follow-up phase of the ACTION trial, having completed enrollment in November. The company looks forward to results in the second quarter of 2002.

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.

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. For more information visit www.guidant.com.