May 8, 2003
Guidant Launches Next Generation Carotid Embolic Protection System in Europe

New Device Captures Emboli Released During Carotid Stenting

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the European launch of its next-generation RX ACCUNET(tm) Embolic Protection System for the treatment of patients with carotid artery disease. The RX ACCUNET System recently received CE Mark approval.

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 Europe and the United States, and the number one cause of disability in adults. About 850,000 cases are reported in Europe each year. Nearly 25 percent of strokes are attributed to embolic events.

The RX ACCUNET System consists of a guide wire with a filter, developed to trap embolic material -- small particles of plaque -- that may be generated during the carotid artery stenting procedure. The filter is designed to allow normal blood flow during the procedure, while trapping embolic particles before they can travel to the blood vessels of the brain, potentially causing a stroke. The device is designed for use with Guidant''s ACCULINK(tm) Carotid Stent System.

"Embolic protection is a major breakthrough in the treatment of carotid artery disease," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. "The launch of Guidant''s latest generation carotid embolic protection system in Europe advances our efforts to establish a minimally invasive alternative to the traditional surgical method for treating carotid artery disease."

In the past, patients with carotid artery disease had 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 some clinical studies have shown to be less effective than traditional surgery in certain patient groups. Carotid stenting with embolic protection devices is seen as a potential alternative for these high-risk patients

"Guidant''s RX ACCUNET System''s rapid-exchange platform was designed to work with the ACCULINK Stent System used in the carotid arteries. It is easy to learn and use and provides for excellent control and minimal procedure time," said Dr. Alberto Cremonesi, director of the interventional unit at the Villa Maria Cecilia Center in Cotignola, Italy.

"The RX ACCUNET System''s next-generation filter design, capture efficiency and enhanced deliverability make it an ideal embolic protection system for use in treating carotid artery disease," said Prof. Klaus Mathias, director of radiology in Dortmund, Germany.

In December 2002, Guidant announced completion of 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. 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 437 registry patients at 41 sites in North and South America. The preliminary 30-day results of the ARCHeR trial were presented on March 30 at the American College of Cardiology meeting in Chicago and at the Society of Interventional Radiology conference in Salt Lake City. The ARCHeR trial utilized Guidant''s previous-generation ACCUNET Embolic Protection System.

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 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.