Sep 23, 1999
Guidant and the University of Medicine and Dentistry of New Jersey Announce Partnership in Landmark Clinical Trial for Treatment of Carotid Artery Disease

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT) a worldwide leader in the treatment of vascular disease, today announced that it is collaborating with the University of Medicine and Dentistry of New Jersey (UMDNJ) in a landmark clinical trial that will evaluate carotid artery stenting (CAS) as an effective means of preventing stroke by comparing it to a surgical procedure known as carotid endarterectomy (CEA). This study, known as the Carotid Revascularization Endarterectomy-Stenting Trial (CREST), is a multi-center randomized clinical trial that is being supported by the National Institute of Neurological Disorders and Stroke (NINDS), of the National Institutes of Health (NIH). Robert W. Hobson II, M.D., at UMDNJ-NJMC, will oversee the study as the principal investigator of the trial.

Guidant''s ACCULINK(tm) Self-Expanding Carotid Stent has been selected as the exclusive stent for this study.

"Guidant is pleased to be a part of this extremely important scientific endeavor and to have our ACCULINK Stent selected exclusively for this study," said Ginger L. Graham, president of Guidant''s Vascular Intervention Group. "By working closely with the University of Medicine and Dentistry of New Jersey and the National Institute of Neurological Disorders and Stroke, we hope to establish that carotid stenting is a viable and effective minimally invasive means for physicians to prevent stroke in their patients who have carotid artery disease."

Guidant has obtained a formal pre-investigational device exemption agreement with the U.S. Food and Drug Administration for the proposed investigational plan and clinical protocol for the CREST Trial. This written agreement is binding in nature between Guidant and the FDA, and can only be changed with the agreement of Guidant, or in the event of a substantial scientific issue essential to determining safety or effectiveness. It represents one of the first pre-IDE agreements between the FDA and industry since implementation of the FDA''s Modernization Act in 1997.

Guidant markets several balloon-expandable stents such as the ACS MULTI-LINK DUET(tm) Coronary Stent System; however, the ACCULINK represents its first self-expandable stent system. The ACCULINK(tm) Self-Expanding Stent System was chosen by the CREST Executive Committee as the exclusive stent for this trial due to its unique design features that are specifically tailored to carotid artery stenting. These features include a highly accurate stent delivery system, a low profile, and a self-expanding tapered stent with variable diameter that may perform better in certain patient anatomy.

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. It 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, which can prevent particles of atherosclerotic plaque from being dislodged and causing a 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. As with any surgical procedure, however, it may have complications related to the method of treatment.

"Guidant is looking forward to participating in the CREST clinical trial and working closely with Dr. Hobson in an effort to determine how to effectively treat patients with carotid artery disease," said Gary Johnson, vice president of clinical research, regulatory affairs, and quality assurance for Guidant''s Vascular Intervention Group. "If it were not for Dr. Hobson''s leadership and dedication, this critical NINDS-supported trial would not be possible."

With approximately 600,000 cases reported each year, stroke is the third-most common cause of death in the U. S. and the number one cause of disability in adults. 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.

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.

The NINDS, an agency of the U.S. Federal Government and a component of the National Institutes of Health and the U.S. Public Health Service, is a lead agency for the Congressionally designated Decade of the Brain, and the leading supporter of biomedical research on disorders of the brain and nervous system. For more information on NINDS or the NIH, visit its website at http://www.ninds.nih.gov.