Jul 6, 1999
Guidant Announces CE Mark Approval to Market its ACS MULTI-LINK TRISTAR Coronary Stent Systems

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced that it has received CE Mark approval for its ACS MULTI-LINK TRISTAR(tm) Coronary Stent Systems.

The ACS MULTI-LINK TRISTAR Coronary Stent System is Guidant''s next-generation stent system indicated for use in de novo lesions (first-time blockages in native coronary arteries) and in saphenous vein grafts (veins harvested from the leg and used as grafts in coronary artery bypass surgery). The ACS MULTI-LINK TRISTAR is the successor of Guidant''s highly successful and world-market-leading ACS MULTI-LINK DUET(tm) Coronary Stent System, and provides the clinician with a stent system that enhances the treatment of coronary artery disease.

Coronary stents act as a scaffolding to support coronary arteries and hold them open. They are often used in conjunction with percutaneous transluminal coronary angioplasty (PTCA). In 1999, more than 1.5 million people worldwide will require an interventional procedure, such as PTCA. Approximately 66 percent of the PTCA procedures will utilize at least one stent.

Since March 1998, over 500,000 of Guidant''s ACS MULTI-LINK DUET stents have been implanted. The ACS MULTI-LINK TRISTAR builds on the proven design of the MULTI-LINK DUET, which includes excellent radial strength, deliverability and visibility, by incorporating new technologies that further enhance performance.

Performance and precision in the deliverability, deployment and implant of the ACS MULTI-LINK TRISTAR Coronary Stent System were enhanced utilizing a variety of new technologies, including S.T.E.P.(tm) Balloon Technology, ACS CritiCoil(tm) Technology and GRIP(tm) Technology. The stent, which is identical to the clinically proven ACS MULTI-LINK DUET stent, is a pre-mounted, balloon expandable coronary stent, available on both RX and OTW platforms. This stent design provides high radial strength and excellent vessel scaffolding without compromising flexibility or uniform stent expansion.

S.T.E.P.(tm) (Short Transitional Edge Protection) Balloon Technology incorporates a unique balloon design, which creates a step-shaped taper at each end of the stent to reduce the amount of balloon material outside the stent. This optimal stent and balloon shoulder configuration minimizes the amount of vessel dilated outside of the stent. It also enables uniform stent expansion during deployment and implantation.

ACS CritiCoil(tm) Technology provides luminal integrity to help ensure flexibility around multiple acute bends. The stent crimping process, known as GRIP(tm) Technology, provides excellent stent retention and smooth surface transition across the stent and balloon.

The delivery balloon, made of XCELON(tm) material, provides sizing flexibility, with a 16 atm-rated burst pressure for high-pressure dilatation. It also utilizes balloon folding technology to ensure even dilatation pressure, concentric stent deployment and excellent balloon refolding. These features enable a physician to easily use the same delivery system for stent deployment and post-stent dilatation.

The ACS MULTI-LINK RX & OTW TRISTAR Coronary Stent System includes diameters that can treat arteries from 2.5 to 4.0 mm (4.5 mm maximum post-dilatation) and is available in lengths of 8, 13, 18, 23, 28, 33, and 38 mm. The 2.75 mm diameter and 33 mm length are new Guidant stent sizes.

"The ACS MULTI-LINK TRISTAR Coronary Stent System is based on our clinically proven ACS MULTI-LINK DUET Coronary Stent System which is currently the world''s leading coronary stent," said Ginger L. Graham, President of Guidant''s Vascular Intervention Group. "We''ve enhanced the technology in the TRISTAR system to enhance delivery and deployment of the stent. These enhancements can make the overall procedure faster, more economical and more beneficial to both patients and physicians."

The ACS MULTI-LINK RX & OTW TRISTAR Coronary Stent Systems further strengthen Guidant''s Vascular Intervention product line, which includes the ACS MULTI-LINK RX ULTRA Coronary Stent System, the ACS RX GEMINI(tm) Coronary Dilatation Catheters, the ACS RX & OTW SOLARIS(tm) Coronary Dilatation Catheters, the ACS HI TORQUE BALANCE MIDDLEWEIGHT(tm) Guide Wire, and the ACS VIKING(tm) Coronary Guiding Catheter.

A global leader in the medical device industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.