Dec 17, 2002
Guidant Completes Enrollment in Clinical Trial to Study Carotid Artery Stenting as Alternative Treatment for High Surgical-Risk Patients

Study Will Evaluate Potential New Minimally Invasive Treatment for Carotid Artery Disease

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced completion of patient enrollment in a clinical trial designed to evaluate the safety and efficacy of carotid artery stenting as a minimally invasive alternative for treating carotid artery disease in patients ineligible for surgery or at high surgical-risk.

Patients with carotid artery disease are at risk for stroke. 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. Stroke is the third-most common cause of death in the United States and the number one cause of disability in adults. Approximately 730,000 cases are reported each year, and an estimated 20 to 30 percent of strokes are attributed to embolic events.

Called ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk Patients), the trial is a prospective, non-randomized, multi-center, single-arm study that treated 513 patients at 41 sites in North and South America. Patients were implanted with Guidant's investigational ACCULINK(tm) Carotid Stent System, designed specifically for the treatment of atherosclerotic lesions in the internal carotid artery, one of the vessels that distributes blood to the brain. During the latter phase of the trial, 303 patients were treated with the ACCULINK Stent System in combination with the investigational ACCUNET(tm) Embolic Protection System, which is designed to trap particles of atherosclerotic plaque during the endovascular stenting procedure.

"Completing enrollment in the ARCHeR clinical trial is a key milestone in Guidant''s efforts to establish a minimally invasive alternative to the traditional surgical method used to treat patients with carotid artery disease," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. "We are very excited about this new field, which may change the way physicians approach the treatment of high surgical-risk patients with carotid artery disease."

"ARCHeR is an important clinical trial of carotid stenting, and used rigorous criteria for qualifying high-risk patients. Our hope is that the ARCHeR study will establish carotid stenting as a good option for high surgical-risk patients. We are looking forward to reporting 30-day interim results of the ARCHeR study in the coming months," said co-principal investigator Mark H. Wholey, M.D., Chairman of the Pittsburgh Vascular Institute in Pittsburgh, Pennsylvania.

Currently, patients with carotid artery disease have two treatment options: carotid surgery--known as carotid endarterectomy--or medical therapy. Some patients have certain risk factors that make them poor candidates for surgery. Often the only treatment alternative for these high-risk patients is medication, which clinical studies have shown to be less effective than traditional surgery in certain patient groups.

"I am enthusiastic about the potential clinical benefits of carotid stenting as a less-invasive alternative to the carotid endarterectomy procedure in high-risk patients," said L. Nelson Hopkins, M.D., Professor and Chairman of Neurosurgery at the State University of New York at Buffalo and co-principal investigator for the ARCHeR clinical trial.

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 more than 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.

This release includes forward-looking statements concerning the therapy. The statements are based on assumptions about many important factors, including regulatory timelines and approvals, continuing clinical and other product developments, and other factors identified on Exhibit 99.1 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company''s newsroom at www.guidant.com/newsroom.