Jan 9, 2002
Guidant CEO Provides Corporate Update and Positive Outlook for 2002

Company Maintains Optimism as it Continues to Advance Drug-Eluting Stent and Heart Failure Programs

Indianapolis, Ind. - Ronald W. Dollens, president and CEO of Guidant Corporation (NYSE and PCX: GDT), provided an update on the company's activities and reiterated continued optimism for growth in 2002 during a presentation yesterday at the 20th Annual J.P. Morgan H&Q Healthcare Conference in San Francisco.

"We saw a strong finish to 2001, and we're expecting to see continued growth in 2002," said Dollens. "The halting of the MADIT II trial at the close of last year has also given us strong momentum heading into the coming year. The existing and emerging markets in which we're involved - implantable defibrillators, drug-eluting stents, resynchronization therapy, beating heart surgery, abdominal aortic aneurysm grafts as well as intravascular radiotherapy - are coming of age, and we're well-positioned to be a global leader in all of them."

During his presentation, Dollens provided updates on three of the company's most prominent programs:

Implantable Defibrillators - Dollens confirmed that in December Guidant filed with the U.S. Food and Drug Administration (FDA) to expand the indications for its implantable defibrillators based on results of the MADIT II trial, which the company sponsored. The study showed that use of an implantable cardioverter defibrillator (ICD) reduced the death rate by 30 percent among heart attack survivors with impaired heart function. An expanded indication could potentially double the number of patients currently indicated for an ICD.

Drug-Eluting Stents - Dollens also reported consistent progress in Guidant's broad drug-eluting stent program. Enrollment proceeds on schedule in the Guidant-sponsored DELIVER clinical trial, with 279 patients already enrolled at 27 centers. When completed, the trial will enroll up to 1,042 patients in approximately 70 centers nationwide. The trial is designed to evaluate the safety and effectiveness of the ACHIEVE(tm) Drug-Eluting Coronary Stent System. The investigational ACHIEVE Stent System is manufactured by Cook Incorporated and utilizes drug-coating technology developed by Cook, and stent and delivery system components supplied by Guidant to Cook. Dollens also noted that 30-day follow-up in Guidant's ACTION clinical trial, supporting the company's internal PHARMA-LINK(tm) Drug Eluting Stent Program, utilizing Actinomycin D, has revealed no safety concerns.

Heart Failure - Dollens further noted that the company is making progress in its ongoing discussions with the FDA regarding the CONTAK(tm) CD/EASYTRAK(tm) system, Guidant's investigational combination cardiac resynchronization therapy (CRT) and ICD system for the treatment of heart failure. Dollens stated that the company is preparing for a launch of the product in the United States in the second quarter of this year pending FDA approval.

Dollens also remarked upon matters of health care policy, underlining the importance of ensuring a positive reimbursement process to make key therapies for cardiac and vascular disease broadly accessible to patients. Dollens was just appointed to the U.S. Health and Human Services Advisory Committee on Regulatory Reform, which met on Monday for the first time. The committee has a one-year charter to make recommendations for changes in four broad areas of concern: health care delivery, health systems operations, biomedical and health services research, and the development of pharmaceuticals and other products.

"I am looking forward to ensuring that there is improved alignment between the processes of the Food and Drug Administration and the Centers for Medicare and Medicaid Services," he said.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions.

 

This release contains forward-looking statements about the company's future financial results, the company's prospects and products in research and development. This information is based upon management's current expectations, but actual results may differ materially from those discussed in the forward-looking statements. Other factors affecting future results include those outlined in Exhibit 99 to the company's Form 10-Q for the quarter ending Sept. 30, 2001.

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