Sep 22, 2000
Guidant Launches Clinical Trial to Study Iliac Artery Stenting as Alternative to Traditional Treatment with Angioplasty

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary and peripheral vascular disease, today announced the start of a clinical trial to determine the safety and efficacy of iliac artery stenting as an alternative for the treatment of iliac artery disease. Approximately 1.5 million people worldwide undergo angioplasty and related interventional procedures each year, a significant number of which are estimated to be interventions in the iliac arteries.

The Guidant-sponsored study, known as MIST (MEGALINK Iliac Stent Trial), is a randomized trial that will enroll 240 patients who have experienced unsatisfactory results from angioplasty to treat blockages in iliac arteries. The MIST trial is designed to evaluate the ability of Guidant''s OTW MEGALINK(tm) SDS Peripheral Stent System to safely and effectively open and keep open over time de novo (first time) or restenotic (re-occurring) lesions in iliac arteries. This clinical study is being conducted at 20 sites throughout the United States and will utilize Guidant''s MEGALINK System. The first patient was successfully treated on September 18, 2000, by Rick McClure, M.D., at Central Baptist Heart Institute in Lexington, Ky.

Since iliac arteries are larger in diameter than coronary vessels, the MEGALINK System was developed to accommodate lesions found in larger diameter vessels. Based on Guidant''s original MULTI-LINK coronary stent platform, the MEGALINK System is currently approved in the United States for the treatment of malignant biliary duct obstructions.

"The MIST trial is designed to evaluate stenting as an efficacious alternative for treating iliac artery disease," said John Laird, M.D., of the Washington Hospital Center in Washington, D.C., who will serve as the principal investigator of the MIST trial. "Many physicians treating patients with this type of peripheral vascular disease will be excited to learn the outcome of Guidant''s iliac artery stenting trial."

A common method of treatment for patients with iliac artery disease is angioplasty, which utilizes a balloon dilatation catheter to expand the blocked area of the artery and restore normal blood flow. Clinical studies have shown, however, that as many as one-third of patients who receive angioplasty experience restenosis - re-occurring blockages of treated arteries - and require repeat visits to their physicians.

If left untreated, occlusions in the iliac arteries may impact blood circulation, as well as cause cramping of the legs and numbness during walking. This type of peripheral artery disease is often incorrectly attributed to arthritis or aging.

Peripheral artery disease is similar to coronary artery disease, in that blood flow through the peripheral vessels is impacted by atherosclerosis, which is the narrowing and hardening of arteries over time. Iliac artery disease is one type of peripheral artery disease.

"Guidant has established itself as a market leader in the treatment of coronary artery disease," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "With the growing awareness among physicians and patients of peripheral artery disease, the development of products such as the MEGALINK System represents a new opportunity for Guidant to provide physicians with leading-edge technology to treat diseases of the peripheral anatomy."

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.