Feb 19, 1999
Guidant Announces FDA Approval for a New Indication for its Coronary Stents, Including a 2.5mm Diameter and a 38mm Length

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT) a world leader in the treatment of coronary artery disease, today announced FDA approval to market the ACS MULTI-LINK DUET(tm) Coronary Stent System for abrupt and threatened abrupt closure in the United States. This approval includes a 2.5 mm diameter stent and a 38mm length stent. The ACS MULTI-LINK DUET stent is the world(tm)s top selling coronary stent.

The FDA approval of the ACS MULTI-LINK DUET Stent for abrupt and threatened abrupt closure now provides physicians with the widest selection of diameters and lengths of any coronary stent product line. This latest FDA approval provides the clinician with a stent product that is effective in the treatment of abrupt and threatened closure including smaller arteries.

Approximately 20 percent of atherosclerotic lesions occur in vessels smaller than 3.0 mm. More than 500,000 patients will require a stent procedure in the US during 1999. Abrupt or threatened abrupt closure occurs when a coronary artery is found to be at risk of reclosure following a previous interventional procedure. The additional 2.5 mm diameter ACS MULTI-LINK DUET stent is available in lengths of 8, 13, 18, 23 and 28 mm. The 38mm length stent is available in diameters of 3.0, 3.5 and 4.0 mm.

The FDA initially approved the ACS MULTI-LINK DUET Coronary Stent System on November 5, 1998 for de novo (first-time narrowing) and restenotic (re-narrowing) lesions in native coronary artery vessels. Previously available sizes include diameters of 3.0, 3.5 and 4.0 mm, and lengths of 8, 13, 18, 23 and 28 mm. This latest FDA market clearance extends the abrupt and threatened abrupt closure indications to these sizes of the ACS MULTI-LINK DUET Stent. Additionally, it includes all sizes of the ACS MULTI-LINK® Coronary Stent System.

"The approval of the additional sizes and clinical applications for the ACS MULTI-LINK DUET Stent product line will enable interventional cardiologists to provide the same outstanding clinical and procedural results of this market-leading product to a larger number of patients," said Ginger L. Graham, president of Guidant(tm)s Vascular Intervention Group.

A coronary stent is used in interventional procedures to keep coronary arteries open following percutaneous transluminal coronary angioplasty (PTCA). The ACS MULTI-LINK DUET Coronary Stent System is based on the design of the highly successful ACS MULTI-LINK® stent. It provides lower profiles, greater deliverability and enhanced visibility over the ACS MULTI-LINK stent.

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(tm)s products and services, visit the company(tm)s Web site at http://www.guidant.com.