Jul 19, 2001
First Patients in Japan Treated with Guidant's Carotid Stent

Clinical Study to Evaluate Novel Stroke Prevention Alternative for Japanese Patients

Indianapolis, Ind. and Tokyo, Japan - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiovascular and vascular disease, today announced that the first patients in Japan have been implanted with the company's investigational ACCULINK? Carotid Stent System. These patients become the first to be enrolled in Guidant's ACCULINK Japan Registry, a clinical study designed to evaluate the ACCULINK System as a non-surgical alternative to the traditional surgical method of restoring blood flow to blocked carotid arteries, which are located on either side of the neck. Stroke can occur when particles from the blocked carotid arteries are dislodged and prevent adequate blood flow to the brain.

The first two patients were treated by Dr. Nobuyuki Sakai at Kobe City General Hospital in Kobe, Japan and Dr. Ichiro Nakahara at Kokura Memorial Hospital in Kokura, Japan. Six sites in Japan will participate in Guidant's ACCULINK Japan Registry, a study that will treat 105 patients with blockages in carotid arteries. Professor Waro Taki, M.D., of Mie University in Tsu, Japan, is serving as principal investigator of this clinical study.

"Currently patients in Japan suffering from carotid artery disease have only surgery or drug therapy as treatment options," commented Professor Taki. "The ACCULINK System appears to be easy to use and well suited for treating carotid artery disease and I look forward to progressing with the ACCULINK Japan Registry."

Potential Means of Reducing Risk of Stroke

Stroke is the third most common cause of death among adults in Japan. Approximately 20 percent of stroke patients in Japan die within one year of suffering a stroke and 30 percent survive only to require continuing medical care for the effects of stroke. More than 26 percent of all medical spending in Japan is directed towards treating patients with heart disease and stroke.

"Stroke is clearly a significant medical issue in Japan, and Guidant is committed to increasing the clinical information about stroke prevention alternatives," said Guidant Corporation's Dana G. Mead, Jr., president, Guidant Japan/Asia Pacific. "We are hopeful that by conducting the ACCULINK Japan Registry we can successfully evaluate carotid stenting as a new treatment for preventing stroke among patients suffering from carotid artery disease."

About the ACCULINK Carotid Stent System

The investigational ACCULINK Carotid Stent System features a unique self-expanding stent that is Guidant's first carotid stent, and was specifically designed for use in the carotid arteries for the prevention of stroke. It is used in the non-surgical carotid artery stenting procedure, which is accomplished by using a catheter that is inserted into a small puncture in the patient's leg. A delivery catheter is advanced through the patient's vasculature to the carotid artery, where the stent is deployed at the site of the atherosclerotic lesion.

The traditional carotid endarterectomy treatment requires the physician to make a surgical incision in the patient's neck at the site of the blockage. This allows the surgeon to then remove the plaque from inside the artery wall.

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.