Jul 24, 2001
Guidant Announces Worldwide Launch of New Self-Expanding Stent System

New Product Introduction Broadens Guidant's Global Line of Non-Coronary Therapies

Indianapolis, Ind. and Menlo Park, Calif. - Guidant Corporation (NYSE and PCX: GDT) today announced the global launch of a new self-expanding stent system for non-coronary anatomy. Guidant is launching its DYNALINK(tm) .035 Biliary Self-Expanding Stent System in the U.S. in conjunction with the launch of its DYNALINK(tm) .035 Peripheral Self-Expanding Stent System in Europe.

Both systems feature the DYNALINK(tm) stent constructed of nitinol, a unique superelastic material that enables the stent to automatically expand at the site of the blockage. The DYNALINK stent is mounted on a new .035" guide wire compatible delivery catheter. This delivery system also features a unique handle designed to allow physicians to more accurately place the DYNALINK stent.

The product introduction follows U.S. Food and Drug Administration (FDA) clearance for its DYNALINK .035 Biliary Self-Expanding Stent System for treating 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. Biliary obstructions can be caused by a variety of medical conditions, including gallstones, tumors of the bile ducts or pancreas, or other tumors that have spread to the biliary system.

The DYNALINK .035 Biliary Stent is the fourth of Guidant's non-coronary stent systems to receive FDA clearance this year, following the approval and subsequent launches of the RX HERCULINK(tm) PLUS, OMNILINK(tm) .018 and OMNILINK(tm) .035 Biliary Stent Systems earlier this year.

"Guidant is launching new, innovative stent products at a rapid pace, making our line of both non-coronary and traditional coronary stents more extensive than ever," said Beverly Huss, president, Endovascular Solutions, Guidant.

Launching New DYNALINK .035 System in Europe

Guidant has CE Marked the DYNALINK .035 Peripheral Self-Expanding Stent System, making the system available in Europe for treating peripheral vascular disease. Guidant's RX HERCULINK(tm) PLUS, OMNILINK(tm) .018 and OMNILINK(tm) .035 Stents were also CE Marked for treating peripheral vascular indications earlier this year.

Peripheral vascular disease, which is characterized by reduced blood flow to the lower extremities due to atherosclerosis, affects more than 12 million people in North America and Europe, with approximately 600,000 newly diagnosed cases each year.

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.