Aug 10, 1999
Guidant Announces First Human Carotid Implants of the ACCULINK Self-Expanding Stent for the Prevention of Stroke

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a worldwide leader in vascular intervention, today announced the first human implants of the ACCULINK(tm) Self-Expanding Stent System, designed for the revascularization of carotid arteries. These successful implants, performed by Dr. Nick Hopkins at the State University of New York-Buffalo''s Millard Fillmore Hospital, began the feasibility trial, which is designed to demonstrate the safety of the ACCULINK System.

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. An estimated 20-30 percent of these 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 and prevent adequate blood flow causing the condition known as stroke.

Studies have shown that treatment of significant carotid artery disease by surgically removing plaque and debris can significantly reduce the future risk of stroke. This surgical procedure, known as carotid endarterectomy (CEA), is performed by making an incision in the patient''s neck at the site of the blockage, which allows the surgeon to remove the plaque from the inside of the artery. Approximately 170,000 of these procedures are performed annually in the U.S.

Results from clinical trials have demonstrated that the CEA procedure yields better results than treatment with drugs alone in select patient populations. However, as with any surgical procedure, it may have complications related to the surgery. Carotid stenting has been proposed and utilized by some physicians as a promising, less-invasive therapy that may reduce procedure time, length of hospital stay, and procedural complications in select groups of patients. Carotid stenting is performed by delivering the stent on a catheter through a small puncture in the femoral artery, located in the groin. The catheter bearing the stent is delivered to the carotid artery through the patient''s vasculature, where the stent is then deployed to cover the atherosclerotic plaque. When expanded, the stent presses against the artery wall to prevent the particles of atherosclerotic plaque from being dislodged and causing a stroke.

While Guidant markets several balloon-expandable stents such as the ACS MULTI-LINK DUET(tm) Coronary Stent System, the ACCULINK represents its first human implant of a self-expandable stent system. The ACCULINK Self-Expanding Stent System retains its shape after implantation and is crush-resistant. This is a critical feature for stents used in the carotid arteries, due to the large degree of movement and flexion in the neck.

"Guidant is hopeful that stenting will prove to be an effective minimally invasive means of treating carotid artery disease without subjecting the patient to an open surgical procedure," said Ginger L. Graham, president of Guidant''s Vascular Intervention Group. "This feasibility study is designed to demonstrate the safety of the ACCULINK System, which would enable us to further pursue definitive clinical studies to establish the efficacy of carotid stenting."

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