Jun 10, 2003
Guidant Leads Clinical Investigation of New Therapy for Stroke Prevention

Second Clinical Trial Advances Efforts to Develop Minimally Invasive Treatment for Carotid Artery Disease

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the enrollment of the first patient in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who are at high risk for stroke and are ineligible for current surgical options or at high surgical-risk.

The clinical trial, called ARCHeR RX, (ACCULINK for Revascularization of Carotids in High-Risk Patients), is a prospective, non-randomized, multi-center, single-arm study that will enroll 145 patients in the United States, Europe and South America. The first patient was treated in late May at the Baptist Heart and Vascular Institute, Knoxville, Tenn.

"This trial is an important next step in Guidant''s strategy to advance carotid artery stenting as a minimally invasive alternative to carotid endarterectomy," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. "Preliminary data from the first ARCHeR trial, presented at the American College of Cardiology and the Society of Interventional Radiology conferences on March 30, have already demonstrated significant potential for the therapy, and we anticipate ARCHeR RX will further establish carotid artery stenting as an important therapy for the large group of patients who are not well-treated by carotid endarterectomy."

Patients with carotid artery disease are at risk for stroke, the third-most common cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. More than 730,000 people are affected by strokes each year in the United States. A stroke can occur when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the blood stream and occlude vessels in the brain. Nearly 25 percent of strokes are attributed to embolic events.

ARCHeR RX is designed to show equivalence in the safety and performance of Guidant''s Rapid Exchange (RX) versions of the ACCUNET and ACCULINK devices with the "over-the-wire" ACCUNET and ACCULINK devices. The primary endpoint for the study is combined death, stroke and myocardial infarction at 30 days. Key secondary endpoints are ipsilateral stroke between days 31 and 365, acute device success of the ACCULINK and ACCUNET, and target lesion revascularization at six and 12 months.

"The RX versions of Guidant''s carotid artery devices are ideal for treating this disease," said Malcolm T. Foster, M.D., director of Cardiovascular Research, Baptist Heart and Vascular Institute, Knoxville, Tenn. "The RX designs are easy to use and provide outstanding device control and minimal procedure time. Additionally, the enhanced capture efficiency of the filter design provides added protection against emboli that could cause stroke."

The executive committee of physicians that will oversee the second-phase study includes: Mark H. Wholey, M.D., chairman of the Pittsburgh Vascular Institute, Pittsburgh, Pa.; L. Nelson Hopkins, M.D., professor and chairman of Neurosurgery at the State University of New York at Buffalo; William Gray, M.D., director of Endovascular Care at the Swedish Medical Center in Seattle, Wash.; Richard Atkinson, associate clinical professor of Stroke Neurology, University of California, Davis; Ronald M. Fairman, associate professor of Surgery and Radiology, and chief, Division of Vascular Surgery, at the University of Pennsylvania in Philadelphia; and Prof. Alberto Cremonesi, M.D., director of the interventional unit at the Villa Maria Cecilia Center in Cotignola, Italy.
About the ACCULINK and ACCUNET

Guidant's investigational RX ACCULINK(tm) Carotid Stent System is designed specifically for the treatment of atherosclerotic lesions in the internal carotid artery, one of the vessels that distribute blood to the brain. Guidant's investigational next-generation RX ACCUNET® Embolic Protection System - which works with the ACCULINK - features an enhanced filter design to more efficiently trap particles of atherosclerotic plaque that might be released during the procedure and may lead to stroke and other complications.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for a better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 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.

This release includes forward-looking statements concerning trial results and development of the therapy. The statements are based on assumptions about many important factors, including final trial results, continuing clinical and regulatory developments, and other factors. Actual results may differ materially. The company does not undertake to update its forward-looking statements.