May 18, 2001
Guidant Announces FDA Approval of its Newest Non-Coronary Stent System

Company's Second Non-Coronary Stent System Approved Within the Past Month

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 approval from the U.S. Food and Drug Administration (FDA) for its OMNILINK .018(tm) Biliary Stent System. This approval comes less than one month after Guidant received FDA approval of its RX HERCULINK PLUS(tm) Biliary Stent System.

"We are very pleased with Guidant's rapid progress in expanding our portfolio of stenting products," said Beverly Huss, president, Endovascular Solutions, Guidant Corporation. "Launching two non-coronary stent systems in less than one month is a remarkable accomplishment that strengthens Guidant's reputation for leadership in developing innovative solutions for treating vascular and non-vascular disease."

About the OMNILINK .018 System

The OMNILINK .018 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, a condition that afflicts approximately 30,000 Americans each year.

The OMNILINK .018 is based on Guidant's MEGALINK(tm) SDS Biliary Stent System, with several important enhancements:

  • A stent design that contains additional metal to enhance the stent's strength and ability to hold open obstructions

 

  • A stent with a lower profile on a delivery catheter for easier navigation through anatomy and improved ability to access blockages

 

  • New XCELON® balloon material, which is thinner, and an optimized stent design to enable a smaller puncture site

 

  • Two diameter-specific different OMNILINK stents for different sized vessels: one designed for vessels with inner diameters of 5mm to 7mm and another for vessels with inner diameters of 8 mm to 10 mm

 

"The OMNILINK .018 Stent System combines the best attributes of Guidant's successful stent and stent delivery systems," said Don Schwarten, M.D., vice president and chief medical officer, Endovascular Solutions, Guidant Corporation. "The result is an optimized stent design that provides physicians with the ability to easily access and treat more resistant obstructions that are found in many challenging cases."

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.

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