Oct 1, 2002
Guidant Announces FDA Clearance and Worldwide Launch of New Product for Treating Peripheral Vascular Disease

High-Performance, Low-Profile System Offers Physicians New Option

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, announced that the company has received FDA clearance to market its new AGILTRAC(tm) .035 Peripheral Dilatation Catheter. The AGILTRAC .035 Peripheral Dilatation Catheter is Guidant''s first dilatation catheter on an .035 platform, completing Guidant''s broad portfolio of products for treating peripheral vascular disease (PVD). FDA clearance follows recent CE Marking of the AGILTRAC .035 Peripheral Dilatation Catheter, which will launch worldwide immediately.

Peripheral vascular disease affects an estimated 10 million patients in the United States alone. The condition is characterized by blockages in vessels supplying the kidneys and limbs. Early stages of peripheral disease may have especially dangerous health implications, as patients may experience high blood pressure, kidney dysfunction, and leg pain. These problems are caused by the narrowing of blood vessels, which restricts normal blood flow.

"Many physicians prefer the familiarity and compatibility of an .035 platform for performing peripheral vascular interventions. Guidant's new AGILTRAC .035 Peripheral Dilatation Catheter is unique in that it offers very low profile and high pressure dilatation combined in one system," said Beverly Huss, president, Endovascular Solutions, Guidant.

This new .035 peripheral dilatation catheter is intended to treat blockages in peripheral arteries through a non-surgical angioplasty procedure. The treating physician inserts the catheter through a small incision and guides the catheter to the peripheral blockage. The physician then inflates the balloon at the site of the blockage, which presses against the artery wall and restores blood flow through the previously blocked area. Guidant currently offers .014 and .018 peripheral dilatation catheters.

"I have always preferred .035 systems for large vessel angioplasty. The new AGILTRAC .035 balloon''s high pressure capabilities and its low profile, combined with a broad range of sizes, makes it an ideal primary balloon dilatation catheter," said Andrew S. Blum, M.D., of Midwest Heart Specialists, Chief of Vascular Interventional Radiology at Elmhurst Memorial Healthcare in Elmhurst, Ill.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for 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.