Nov 10, 2000
Guidant Launches Cerebral Stenting Trial

Clinical Trial Will Assess Stenting of Cerebral Arteries

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of vascular disease, has enrolled the first patients in a clinical trial to determine the safety and feasibility of stenting in patients with cerebrovascular disease. Guidant's SSYLVIA (Stenting in SYmptomatic atherosclerotic Lesions of Vertebral and Intracranial Arteries) trial is a non-randomized, prospective study that will enroll approximately 30 patients with cerebral atherosclerosis-the narrowing or hardening of arteries that occurs over time. This study will be conducted at five centers in the United States, as well as eight centers outside the U.S.

The SSYLVIA trial will exclusively use Guidant's NEUROLINK® System, which is designed to treat atherosclerosis of the intracranial arteries and extracranial vertebral arteries-cerebral vessels that travel up the back of the neck on either side of the spinal cord and join at the base of the skull. The first two patients were successfully treated on Nov. 9, 2000, by Stanley Barnwell, M.D., Ph.D., neurointerventionalist at the Oregon Health Sciences University in Portland, Ore.

"The beginning of the SSYLVIA trial is a significant milestone in Guidant's overall effort to address the important challenge of stroke prevention," said Jay Watkins, president of Guidant's Cardiac & Vascular Surgery Group and Compass, Guidant's business development and ventures group. "We are hopeful that the study of stenting in cerebral arteries may ultimately provide physicians with a new method of stroke prevention for their patients with cerebrovascular disease." The NEUROLINK System and the company's neurovascular venture are key initiatives within Compass.

If left untreated, atherosclerosis of cerebral arteries can lead to ischemic stroke. This type of stroke occurs when a cerebral artery narrows due to the accumulation of plaque, or when a clot obstructs the artery, blocking the flow of blood. This leaves the affected area of the brain without oxygen and, within a short period of time, brain tissue in that location dies, often leaving the part of the body controlled by these cells with limited or no function. The American Heart Association (AHA) estimates that ischemic strokes are responsible for between 70 percent and 80 percent of the approximately 600,000 stroke cases reported in the United States each year.

More distressing than the frequency of stroke is the way in which stroke impacts its victims' quality of life. According to the AHA, brain injury from a stroke often results in paralysis or weakness on one side of the body. Stroke may also affect the survivors' memory, senses, motor activity and speech.

Small, temporary strokes called transient ischemic attacks (TIAs) can also result from atherosclerosis of cerebral arteries. TIAs occur when a cerebral vessel is temporarily occluded. Although TIAs may leave the patient with no lasting effects, they often precede strokes. The AHA estimates that about 50 percent of patients who have TIAs experience stroke within one year of the TIA.

"Endovascular stenting is a potentially important advance in the treatment of certain patients suffering from cerebrovascular atherosclerosis," said Helmi L. Lutsep, M.D., associate director of the Oregon Stroke Center at Oregon Health Sciences University, who will serve with Barnwell as co-investigators for Guidant's SSYLVIA trial. "These patients are at a high risk for stroke and their treatment options are currently limited to drug therapy."

Added Barnwell, "Guidant's NEUROLINK System offers the flexibility needed to access cerebrovascular lesions, which historically has been one of the key limiting factors to establishing an endovascular procedure for treating atherosclerosis in these arteries."

Guidant's investigational system is comprised of a balloon dilatation catheter for pre- and post- dilatation and the NEUROLINK stent, which is pre-mounted on a delivery catheter. A physician gains access to the vasculature through a small incision in the patient's femoral artery, located in the groin. This flexible catheter is then guided through the patient's vasculature into the cerebral artery and the site of the atherosclerotic plaque, where the balloon is inflated to expand the stent on its tip. Once deployed, the NEUROLINK stent serves as scaffolding to hold previously blocked arteries open, improving blood flow through the cerebral artery and potentially reducing the risk of future ischemic stroke.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.