Oct 18, 2000
Guidant Launches its DYNALINK Biliary Self-Expanding Stent System

Biliary Stent Further Extends Company''s Line of Non-Coronary Stent Systems

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary and peripheral vascular disease, announced today that it has received U.S. Food and Drug Administration clearance to market its DYNALINK(tm) Biliary Self-Expanding Stent System. The DYNALINK is Guidant''s first FDA-cleared self-expanding stent system.

"Guidant''s DYNALINK Biliary Self-Expanding Stent System provides physicians with a self-expanding stent that is deliverable and can be accurately and predictably placed at the site of the occlusion," said Don Schwarten, M.D., vice president and chief medical officer for Guidant''s Cardiac & Vascular Surgery Group.

Guidant''s DYNALINK System is comprised of the DYNALINK Stent and Delivery System. After entering the access site through a small puncture in the skin, a physician guides the flexible catheter to the site of the blockage. Once deployed, the DYNALINK Stent serves as scaffolding to hold previously occluded areas open.

The DYNALINK System is 6F sheath compatible, which allows for a lower system profile and enables physicians to perform the stenting procedure through a smaller puncture site. The stent is constructed from nitinol, a self-expanding material that is crush-resistant and is designed to minimize stent shortening. The DYNALINK Stent design, when combined with the delivery system, results in highly accurate stent deployment.

"The U.S. launch of the DYNALINK Biliary Self-Expanding Stent System is another milestone in Guidant''s strategy of developing a comprehensive line of non-coronary products," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "The launch of Guidant''s first FDA-cleared self-expanding stent is testimony to our continuous commitment to bring new and innovative products to market."

Each year, approximately 30,000 Americans are affected by biliary obstructions, which are blockages found in the ducts that carry fluids from the liver to the gallbladder or from the gallbladder to the small intestine.

The DYNALINK Biliary Self-Expanding Stent System joins a family of Guidant products designed specifically for non-coronary anatomy that are currently FDA-cleared and in clinical evaluation. In September of this year, Guidant began enrolling patients in the MIST (MEGALINK Iliac Stent Trial) study, which will evaluate the ability of the Guidant''s OTW MEGALINK(tm) SDS Peripheral Stent System to safely and effectively keep open iliac arteries. In July of this year, Guidant launched the HERMES (HERculink Multicenter Evaluation of Renal Stenting) study, which will treat patients with Guidant''s RX HERCULINK(tm) 14 Peripheral Stent System who have experienced unsatisfactory results from angioplasty in renal arteries. The OTW MEGALINK and RX HERCULINK Systems are currently cleared in the U.S. for biliary indications.

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.