May 16, 2000
Guidant Launches Clinical Trial to Study Carotid Artery Stenting as a Stroke Prevention Alternative for High-Risk Patients

Indianapolis, IN and Santa Clara, CA - Guidant Corporation (NYSE and PCX: GDT), a global leader in the development of technologies for the treatment of carotid artery and peripheral vascular disease, has launched a clinical trial to evaluate the efficacy of carotid artery stenting as a minimally invasive alternative to surgery for treating carotid artery disease and determine the incidence of stroke in high-risk patients.

Called ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk Patients), the trial is a single-arm, prospective, multi-center study that will treat about 400 patients at approximately 30 sites. The co-principal investigators for this trial are L. Nelson Hopkins, M.D., Professor and Chairman of Neurosurgery at the State University of New York at Buffalo and Mark H. Wholey, M.D., Chairman of the Pittsburgh Vascular Institute in Pittsburgh, Pennsylvania.

As part of the trial, the first patient was successfully implanted with Guidant's investigational ACCULINK(tm) stent by Hopkins at the Millard Fillmore Hospital in Buffalo, New York. The ACCULINK stent is designed to treat patients who suffer from carotid artery disease.

The American Heart Association (AHA) estimates that 20-30 percent of all strokes are caused when particles of atherosclerotic plaque are dislodged from the carotid artery wall. As these particles travel through the bloodstream they can occlude vessels in the brain, preventing adequate blood flow and causing the condition known as stroke. According to the AHA, stroke is the third most common cause of death and the number one cause of disability in adults with approximately 600,000 stroke victims reported each year in the United States. Approximately 150,000 strokes each year result in death.

Currently, patients with carotid artery disease have two treatment options to prevent stroke: carotid surgery-known as carotid endarterectomy-or medical management. Some patients who may be candidates for endarterectomy have other risk factors that make them poor candidates for surgery, including advanced age, significant coronary artery disease, uncontrolled diabetes and significant respiratory problems. 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 preventing strokes in certain patient groups.

"The ARCHeR clinical trial addresses a major unmet public health need," said Hopkins. "The trial is designed to establish a minimally invasive alternative to carotid endarterectomy for high-risk patients, thereby reducing their risk of possible complications from untreated carotid artery disease."

Carotid stenting has been proposed and utilized by some physicians as a promising, less invasive alternative to the carotid endarterectomy procedure. Endarterectomy patients are often placed under general anesthesia while the surgeon makes an incision in the patient''s neck at the site of the blockage and removes the plaque from inside the artery. While earlier clinical trials have shown that endarterectomies are effective in certain patient populations, patients may suffer side effects from the anesthesia and risk potential nerve damage in their necks from the surgical incision.

Carotid artery stenting is performed by delivering the stent on a catheter through the femoral artery, which is located in the groin. The catheter carrying the stent is delivered to the carotid artery through the patient''s vasculature, where the stent is deployed to cover the atherosclerotic plaque. Once expanded, the stent presses against the artery wall and covers the plaque to prevent particles from dislodging and potentially occluding blood vessels, which can cause a stroke.

"We are excited about the potential clinical benefits of a minimally invasive alternative to the traditional surgical method used to treat carotid artery disease," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "Our hope is that the ARCHeR study will establish carotid stenting as an effective means of reducing stroke among high-risk patients."

The launch of the ARCHeR clinical trial supports Guidant''s initiative to develop a comprehensive program for carotid therapy and follows the successful safety trial of Guidant''s ACCULINK(tm) Carotid Stent System for carotid therapy. This system is designed for precise deployment over atherosclerotic plaque in the carotid artery, allowing physicians to place the stent within one millimeter of the target area. The self-expanding ACCULINK is Guidant''s first stent for the carotid artery and is available in tapered sizes to fit a patient''s unique anatomy.

Guidant''s ACCULINK Carotid Stent System recently received an Investigational Device Exemption (IDE) for use in the ARCHeR trial and the upcoming Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST). Guidant is collaborating with the University of Medicine and Dentistry of New Jersey for the CREST study, which is being supported by the National Institute of Neurological Disorders and Stroke, of the National Institutes of Health. Guidant''s ACCULINK was selected as the exclusive stent for this trial.

A global leader in the medical device industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.