Oct 3, 2000
Guidant Announces FDA Approval of its MULTI-LINK TETRA Coronary Stent System

Innovative, New System Represents Guidant''s Eighth Major Product Approval in Four Months. Market Anticipation of New Coronary Stent Impacts Third Quarter Revenues

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, announced today that it has received U.S. Food and Drug Administration approval to market its MULTI-LINK TETRA(tm) Coronary Stent System. The MULTI-LINK TETRA represents Guidant''s fourth coronary stent platform, all of which were developed internally by the company.

More than 1.5 million Guidant stents have been used to successfully treat patients with coronary artery disease since the company launched its first general use stent in 1997. Since that time, the company has successfully implemented its strategy of bringing a new stent that is capable of treating most patients to the market on an annual basis, while supplementing its product offering with lesion-specific devices to treat more challenging anatomy.

The MULTI-LINK TETRA was designed to deliver the highest levels of four key design attributes in a single system - scaffolding, flexibility, conformability and visibility. While other stents may compromise among these four attributes, Guidant''s MULTI-LINK TETRA delivers all four in one design.

"The FDA approval of the MULTI-LINK TETRA Coronary Stent System is the latest example of Guidant's continuing leadership in coronary stenting and the medical technology arena in general," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "We''re proud once again of our seamless execution in product development and expertise in clinical programs that consistently deliver life-saving innovation - beginning in the research and development lab, progressing smoothly through clinical trials and regulatory approval, and finally into the hands of physicians. These efforts have enabled the MULTI-LINK TETRA to be released in the U.S. just nine months after the release of the MULTI-LINK TRISTAR(tm) Coronary Stent System, which is currently the market-leading stent."

Guidant''s product development efforts have established the company as the world-market leader in stents and stent delivery systems. With each new stent system launched in the U.S., Guidant has been able to build on its market-leading position to achieve over 50 percent of the U.S. stent market. Launched in Europe in May of this year, the MULTI-LINK TETRA continued to propel the company''s growth in this strategically important market'"in the first three months of the MULTI-LINK TETRA launch, Guidant stent units in Europe were up 18 percent over the same period the previous year.

The U.S. market release of the MULTI-LINK TETRA follows the September 8, 2000 launch of Guidant''s MULTI-LINK ULTRA(tm) Coronary Stent System - the company''s first stent designed specifically for large diameter vessels. These two coronary stent systems follow Guidant''s launch of an unprecedented array of interventional cardiology products. Over the past four months, Guidant has also received FDA approval of its RX CrossSail(tm) Coronary Dilatation Catheter, OTW OpenSail(tm) Coronary Dilatation Catheter and VIKING OPTIMA(tm) XT Coronary Guiding Catheter, which further expand the company''s leadership position in the interventional cardiology market.

"The MULTI-LINK TETRA is the new benchmark for coronary stenting," said Dean Kereiakes, M.D., of Christ Hospital in Cincinnati, Ohio, who is the principal investigator for Guidant''s MULTI-LINK TETRA registry. "In the past, physicians were often forced to sacrifice one desirable stent feature for another. For example, greater flexibility would compromise the quality of scaffolding or visibility of the stent. The MULTI-LINK TETRA has succeeded in effectively incorporating all of these key design attributes into a single system."

The MULTI-LINK TETRA combines a number of proprietary technological advances into a single product that performs unlike any other previously available stent:

  • V.T.S.(tm) (Variable Thickness Strut) is the innovative technology that allows the stent to provide flexibility, conformability, scaffolding and radiopacity all in one stent design. This unique technology provides flexibility and radiopacity (visibility) by varying the thickness of the struts to be thinner in certain areas and thicker in other areas.

 

  • GRIP(tm) technology, Guidant''s stent crimping process, delivers enhanced stent retention and smooth surface transitions across the stent and delivery system. This ensures that the stent remains securely attached to the delivery system as the stent is navigated through the patient''s vasculature.

 

  • S.T.E.P.(tm) (Short Transitional Edge Protection) technology provides an optimal configuration of stent length and working balloon to minimize the amount of vessel dilated outside of the stent. This technology also enables uniform stent expansion during deployment and implantation.

 

  • Hydrocoat hydrophilic coating, which covers the delivery system''s catheter tip, balloon tapers and distal shaft to reduce friction, allows for easier negotiation through tortuous anatomy.

 

  • A new flexible catheter tip improves tracking, lesion crossing and stent re-crossing.

 

"The quality and rate of Guidant''s new product introductions have solidified our reputation for innovative excellence and given us a leadership position in the cardiovascular markets we serve," said Ronald W. Dollens, president and chief executive officer of Guidant. "The MULTI-LINK TETRA approval coupled with the recently announced approval to market the world''s smallest, most advanced, dual-chamber implantable defibrillator - VENTAK PRIZM 2 - are evidence of the strength of our capabilities."

Given the MULTI-LINK TETRA''s leading European market position and anticipation of the availability of the MULTI-LINK TETRA in the U.S., some Guidant customers have recently reduced their replacement of inventories of the company''s previous offering, the MULTI-LINK TRISTAR(tm) Coronary Stent System. This reduction in inventory levels in anticipation of the MULTI-LINK TETRA lowered revenues for the third quarter.

The company now expects total revenues for the quarter, including the adverse exchange rate impact, to be approximately $600 million. Guidant management believes that third quarter earnings of $0.40 per share may still be attainable.

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.

 

This release contains forward-looking statements about the company''s future financial results and the company''s prospects. This information is based upon management''s current expectations, but actual results may differ materially from those discussed in the forward-looking statements. Factors affecting future results include those outlined in Exhibit 99.1 to the company''s Form 10-Q filed August 2000.

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