Nov 9, 2001
Guidant and Cook Announce FDA Approval To Begin U.S. Clinical Trial With Paclitaxel-Coated Stent

First U.S. Patient Treated in Pivotal Clinical Trial

Indianapolis, Ind. - Guidant Corporation (NYSE and PCX: GDT) and Cook Incorporated today announced Investigational Device Exemption (IDE) approval and the enrollment of the first patient in the U.S. clinical trial for Cook's paclitaxel-coated stent, which will be distributed exclusively by Guidant. The new ACHIEVE(tm)Stent System is manufactured by Cook Incorporated and utilizes drug-coating technology developed by Cook, and stent and delivery system components supplied by Guidant to Cook. The trial will serve as the basis for Guidant's submission for U.S. Food and Drug Administration (FDA) approval of a paclitaxel-coated stent system.

"We are excited to begin this important trial on schedule and expect enrollment to proceed smoothly," said John Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "Over the past year, Guidant has made substantial progress in advancing its drug delivery stent program. As we rapidly advance in the clinical evaluation phase in both the paclitaxel-coated stent provided through our agreement with Cook, and our internal PHARMA-LINK(tm) Drug Eluting Stent Program utilizing Actinomycin-D, we are well on our way toward providing our customers with the broadest and deepest drug-coated stent product line in the industry."

"Receiving prompt approval from the FDA for such a major clinical trial is very exciting to everyone at Cook," said John DeFord, Ph.D., president and chief executive officer of Cook Incorporated. "We will continue our strategic efforts to demonstrate positive clinical results with paclitaxel so the potential benefits of this technology can be made available to heart disease patients in the most timely manner possible."

The pivotal trial, called DELIVER, is a multi-center, randomized study that will enroll up to 1,042 patients in approximately 70 centers nationwide. This initial approval involves a phased enrollment of 200 patients at 20 investigational sites. Patients enrolled in DELIVER will be treated for de novo lesions up to 25 mm in length in native coronary arteries 2.5 mm to 4.0 mm in diameter.

William O'Neill, M.D., Director, Division of Cardiology, Co-director, Beaumont Heart Center of William Beaumont Hospital in Royal Oak, Michigan, and William Knopf, M.D., of St. Joseph's Hospital in Atlanta, Georgia, will serve as the principal investigators of the trial. The first patient enrolled in the trial was treated today by Dr. Louis Cannon at St. Mary's Medical Center in Saginaw, Michigan.

In August 2001, 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. Last month, an investigation device exemption was filed with the U.S. Food and Drug Administration to begin the DELIVER trial.

With international headquarters in Bloomington, Ind., privately held Cook® (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has been committed to product innovation, skilled hand-craftsmanship and unsurpassed customer satisfaction, earning the company global recognition among medical professionals. Cook Incorporated is acknowledged as an innovator in diagnostic and interventional medicine. More than 40 companies in the United States, Europe, Canada, Australia and Asia design, produce, manufacture and distribute Cook brand medical devices to physicians and other medical professionals around the world.

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.