Oct 3, 2002
Guidant Receives Humanitarian Device Exemption for New Intracranial Stent

NEUROLINK Stent May Provide Hope for Patients at High Risk for Recurrent Stroke

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced that the company has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE) for its NEUROLINK® System designed to treat atherosclerosis of the intracranial arteries, the vessels that distribute blood through the brain. Under the HDE approval, patients with recurrent stroke due to intracranial atherosclerosis who have failed medical therapy may be treated with the NEUROLINK System.

"We believe that endovascular stenting will provide new hope to high-risk patients with cerebral atherosclerosis who continue to have symptoms while on drug therapy and have no other treatment options," said Beverly Huss, president, Endovascular Solutions, Guidant. "The NEUROLINK System leverages Guidant''s broad stent capabilities established with our market-leading coronary and biliary stent systems. We are pleased that the system has received FDA approval, a significant milestone in Guidant''s overall effort to address stroke prevention."

The NEUROLINK System, the only device of its kind approved for use in the United States, consists of a balloon-expandable stainless steel stent with delivery catheter and a balloon dilatation catheter. Approval for the device was granted following FDA review of data from Guidant's SSYLVIA (Stenting in SYmptomatic atherosclerotic Lesions of Vertebral and Intracranial Arteries) trial, a non-randomized, prospective safety and feasibility study that enrolled 61 patients with neurovascular atherosclerosis. The study was conducted at five centers in the U.S. and four centers in Europe.

"We are pleased with the performance of the NEUROLINK System, which has demonstrated the degree of flexibility necessary to access difficult-to-reach atherosclerosis in the cerebral vessels," said Dr. Stanley Barnwell of Oregon Health & Science University, in Portland. "Based on the results of the SSYLVIA trial, we have hope that endovascular stents could lower the risk of recurrent stroke in this patient population."

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 and 80 percent of the approximately 600,000 stroke cases reported in the United States each year. Of these ischemic strokes, approximately 8 percent are due to intracranial atherosclerosis.

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. Stroke may also affect the survivors' memory, senses, motor activity and speech.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for a better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, 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.