Jun 19, 2001
Guidant Receives FDA Clearance for New Biliary Stent System

New Product Offering Further Expands Guidant's Stent Product Line

Indianapolis, Ind. and Menlo Park, Calif - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiovascular and vascular disease, has received clearance from the U.S. Food and Drug Administration (FDA) for its newest stent system, the OMNILINK .035(tm) Biliary Stent System. The OMNILINK .035 System is intended for the treatment of malignant biliary obstructions-blockages that form in ducts that carry fluids from the liver to the gallbladder or from the gallbladder to the small intestine.

The OMNILINK .035 clearance follows several previous FDA clearance and approvals of Guidant stent systems in the U.S. this year, including the RX HERCULINK PLUS(tm) Biliary Stent System, OMNILINK .018(tm) Biliary Stent System and the MULTI-LINK PENTA(tm) Coronary Stent System.

"We expect the OMNILINK .035 System to build on the success of the other non-coronary stent systems Guidant has launched this year," said Guidant Corporation's Beverly Huss, president, Endovascular Solutions. "Adding the OMNILINK .035 System to our product line will give our physician customers access to an even broader collection of stent systems to suit a variety of different sized blockages."

About the OMNILINK .035 Biliary Stent System

The OMNILINK .035 System is compatible with a .035" guide wire, and is Guidant's first offering of a stent system designed for use with a slightly larger diameter .035" guide wire. Guidant's OMNILINK .018 System, which received FDA clearance last month, features the same OMNILINK Stent mounted on a delivery system designed for use with a thinner .018" guide wire. Guidant offers the OMNILINK .035 System with two diameter-specific stents for different sized blockages. The smaller OMNILINK .035 Stent has inner diameters of 5 mm to 7 mm and the larger stent has inner diameters of 8 mm to 10 mm.

One of the key features of the OMNILINK .035 delivery system is the new, thinner XCELON® balloon material, which is designed to give the delivery system a lower profile to enable a smaller puncture site. This delivery system builds on the MEGALINK(tm) SDS Biliary Stent System design, and was developed to improve navigation through anatomy and the ability to access blockages.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.