Dec 23, 1999
Guidant Announces FDA Approval to Market its TRISTAR Coronary Stent System in the U.S.udy Carotid Artery Stenting and Carotid Endarterectom

Indianapolis, IN and Santa Clara, CA - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced that the U.S. Food and Drug Administration has approved its ACS MULTI-LINK RX TRISTAR(tm) and ACS MULTI-LINK OTW TRISTAR(tm) Coronary Stent Systems for marketing in the U.S.

Launched in Europe in September of this year, the TRISTAR is currently the market-leading stent in Europe. By November, its second full month of availability, the TRISTAR accounted for 75 percent of Guidant''s European stent sales. It is the successor to Guidant''s highly successful and world-market-leading ACS MULTI-LINK DUET(tm) Coronary Stent System, which has been implanted in more than 700,000 patients worldwide.

Coronary stents are metal tubes that function as 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 patients worldwide have been treated with an interventional procedure, such as PTCA. Nearly two-thirds of those procedures utilized at least one stent.

The TRISTAR System is indicated for use in de novo (first-time blockages) and restenotic (re-occurring blockages) lesions in native coronary arteries. It is a pre-mounted, balloon-expandable coronary stent, available on both rapid-exchange and over-the-wire platforms. This stent design provides high radial strength, excellent vessel scaffolding, and superb visibility, without compromising flexibility and conformability.

The TRISTAR System incorporates a variety of Guidant-developed technologies that are designed to enhance deliverability, deployment and implantation of the stent. These technologies include:

  • S.T.E.P.(tm) (Short Transitional Edge Protection) Balloon Technology, which incorporates a unique balloon design that creates a step-shaped taper at each end of the stent to reduce the amount of balloon material outside the stent. This 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, which improves deliverability by maintaining the round lumen shape of the catheter and ensures flexibility around multiple acute bends.

 

  • GRIP(tm) Technology, which is a stent-crimping process, provides excellent stent retention and smooth surface transition across the stent and balloon.

 

  • XCELON(tm) balloon material, which provides sizing flexibility, with a 16 atm-rated burst pressure for high-pressure stent deployment.

 

  • Tri-fold balloon technology, which ensures accurate dilatation, concentric stent deployment and excellent balloon refold.

 

"The ACS MULTI-LINK TRISTAR Coronary Stent System represents another important advance by Guidant Corporation in the treatment of coronary artery disease," said Ginger L. Graham, president of Guidant''s Vascular Intervention Group. "Several new technologies, which were developed by the outstanding employees at Guidant, have allowed us to create a significantly advanced stent system that we believe will enhance the ability of interventional cardiologists to effectively treat their patients."

The TRISTAR System includes 2.5, 2.75, 3.0, 3.5 and 4.0 mm (4.5 mm maximum post-dilatation) diameters and is available in lengths of 8, 13, 18, 23, 28, 33, and 38 mm. The 2.5 mm and 2.75 mm diameter and 33 mm and 38 mm sizes are indicated solely for abrupt and threatened abrupt closure. The 2.75 mm diameter and 33 mm length are new Guidant stent sizes.

The ACS MULTI-LINK RX TRISTAR(tm) Coronary Stent System and the ACS OTW TRISTAR(tm) Coronary Stent System further strengthen Guidant''s product line of vascular intervention products. Among them are the ACS RX GEMINI(tm), PHOTON(tm) and SOLARIS(tm) Coronary Dilatation Catheters, the ACS HI TORQUE BALANCE(tm) family of Guide Wires, and the ACS VIKING(tm) Coronary Guiding Catheter. Guidant''s Vascular Intervention Group is based in Santa Clara, CA.

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.

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