Oct 21, 2004
Guidant Begins Enrollment in New Study of Carotid Stenting

CAPTURE Will Advance Understanding of Carotid Stenting In High-Risk Patients at 150 U.S. Sites

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) today announced that the company has begun enrollment in CAPTURE (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events), an FDA-required post-approval study of carotid artery stenting performed by physicians from multiple specialties. The study will utilize Guidant's carotid stent and embolic protection system. As announced in its final decision last week, the Centers for Medicare & Medicaid Services (CMS) will provide expanded payment coverage to include high-risk patients treated as part of this and other FDA-required post-approval studies of carotid artery stenting. Guidant is currently the only company with a carotid stent and embolic protection system on the market in the United States.

CAPTURE is part of Guidant's post approval study plan that will include at least 1,500 patients receiving Guidant's FDA-approved ACCULINK(tm) Carotid Stent System and ACCUNET(tm) Embolic Protection System at approximately 150 sites in the United States. The primary endpoint of the study will be a composite of stroke, death and heart attack at 30 days following the carotid stenting procedure.

"For patients who are ineligible or at high risk for traditional surgery, carotid stenting provides a minimally invasive breakthrough therapy to reduce the risk of stroke," said Beverly Huss, president, Guidant Endovascular Solutions. "This additional data on carotid stenting performed by a variety of physicians from across the nation will further advance our knowledge of this important new therapy."

Guidant's devices will be available only to physicians with the appropriate training and prerequisite experience for performing carotid interventions. The company has worked closely with the FDA, medical societies and leading practitioners to develop targeted training programs in the use of the ACCULINK/ACCUNET Systems for physicians based on their experience level.

About Carotid Artery Disease and Stroke

Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die.

Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant 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.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. For more information about carotid stenting, including illustrations, fact sheets and an animation, please visit www.guidant.com/carotidmediakit.