Sep 23, 2003
Guidant Completes Enrollment in 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 Santa Clara, Calif. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced completion of patient enrollment in its second clinical trial designed to evaluate carotid artery stenting as a minimally invasive alternative for patients who 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, nonrandomized, multi-center, single-arm study that enrolled a total of 145 patients in the United States, Germany, The Netherlands, Belgium, and Argentina. The trial utilizes Guidant''s next-generation embolic protection device, the RX ACCUNET(tm), and a rapid exchange stent system, the RX ACCULINK(tm) carotid stent. The first patient was treated in late May 2003.

"Completing enrollment in this important study is a key milestone 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. "We are pleased with the progress that has been made in the ARCHeR RX trial. Preliminary 30 day data from the first ARCHeR trial have 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."

"The RX designs provided excellent device control and minimal procedure time," said William Gray, M.D., director of Endovascular Care at the Swedish Medical Center in Seattle, Wash., and an Executive Committee member overseeing the trial. "In addition, we were impressed with the enhanced performance of the RX ACCUNET, a next-generation embolic protection device which provides added protection against emboli that could cause stroke if released during the procedure."
Patients with Carotid Artery Disease at Risk for Stroke

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.
Current Treatment Requires Incision in Neck

Carotid endarterectomy is currently the standard surgical method for restoring blood flow within the carotid arteries. It requires an incision in the patient''s neck and artery to remove plaque and debris from inside the vessel wall, thereby reducing the incidence of an embolic stroke. Approximately 160,000 carotid endarterectomies are performed each year in the United States.
About the ARCHeR RX Clinical Trial

The ARCHeR RX clinical trial 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 RX ACCULINK and RX ACCUNET, and target lesion revascularization at six and 12 months. Thirty-day follow-up results for the study will be presented at an upcoming scientific meeting.
About the ACCULINK and ACCUNET

Guidant's investigational RX ACCULINK 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.