Jul 14, 2000
Guidant Launches Study to Evaluate New Embolic Protection System

Indianapolis, IN and Santa Clara, CA - As part of its comprehensive program to treat carotid artery disease, Guidant Corporation (NYSE and PCX: GDT) has launched a study to evaluate the safety and feasibility of its investigational ACCUNET(tm) Embolic Protection System as a potential means of reducing stroke during minimally invasive carotid artery stenting procedures. The trial is a multi-center feasibility study that will treat patients at approximately 12 sites, primarily in North America.

The first patient was successfully treated by Subbarao Myla, M.D., FACC, at Fountain Valley Regional Hospital and Medical Center in Fountain Valley, California. Myla utilized the ACCUNET while implanting the patient with Guidant''s investigational ACCULINK(tm) Carotid Stent System.

The 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 brain and potentially occlude blood vessels, causing the condition known as stroke.

"This first carotid stenting procedure using Guidant''s ACCUNET System is a very important development for carotid artery therapy," said Myla. "The ACCUNET device is clearly a major step forward in helping increase acceptance of carotid stenting by potentially reducing the complications associated with this procedure."

"As physician acceptance of carotid stenting continues to increase, so does the need for clinical data on embolic protection devices," added William Gray, M.D. of the Swedish Medical Center in Seattle, Washington, who will oversee the clinical study as principal investigator.

Carotid artery stenting has been proposed and utilized by some physicians as a promising, less invasive alternative to the conventional surgical method used to treat blockages in the carotid arteries. The ACCUNET Embolic Protection System was designed for use with Guidant''s ACCULINK Carotid Stent System. The ACCULINK stent is designed for deployment over atherosclerotic plaque, preventing particles from dislodging and potentially causing stroke.

Data from the American Heart Association points to stroke as the third-most common cause of death in the United States and the number one cause of disability in adults. Approximately 600,000 cases are reported each year, with an estimated 20-30 percent of strokes caused when particles of atherosclerotic plaque that may have dislodged from the carotid artery wall travel through the bloodstream and obstruct cerebral vessels.

"Embolic protection is the latest breakthrough in the treatment of carotid artery disease," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "Our ACCUNET feasibility study is vital in assessing the safety of what may be an exciting addition to carotid artery stenting procedures.

"We''re committed to developing a comprehensive program for carotid therapy and hope that the ACCUNET System will ultimately help to further the acceptance of stenting as an effective alternative to traditional carotid artery surgery."

Studies have shown that treatment of carotid artery disease by surgically removing plaque and debris can significantly reduce a patient''s future risk of stroke. This surgical procedure, known as carotid endarterectomy, often requires patients to be placed under general anesthesia while a surgeon makes an incision in the patient''s neck at the site of the blockage and removes plaque from inside the artery. As with any surgical procedure, however, it may have complications related to the method of treatment.

Guidant has spent several years developing a carotid therapy program and is collaborating with the University of Medicine and Dentistry of New Jersey for the upcoming CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) clinical trial to investigate carotid artery stenting as an alternative to carotid endarterectomy. This multi-center randomized clinical trial is being supported by the National Institute of Neurological Disorders and Stroke (NINDS), of the National Institutes of Health (NIH).

Guidant has also recently launched the ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk Patients) clinical trial to evaluate carotid artery stenting in patients who may need carotid endarterectomies but are poor candidates for surgery. Guidant''s ACCULINK is the exclusive stent for both the CREST and ARCHeR trials.

A global leader in the medical technology 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 www.guidant.com.