Feb 6, 2001
Guidant's Drug Eluting Stent System Shown to Reduce Restenosis in Pre-Clinical Models

Human Evaluation Expected to Begin in the Second Quarter of This Year

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced promising results from a series of pre-clinical studies with its PHARMA-LINK(tm) Stent System Program. Preliminary angiographic and intravascular ultrasound results demonstrated a marked reduction in the growth of cells at the site of the drug eluting stent in comparison to stent placement without a drug. In addition, histologic data indicated a significant reduction in hyperplasia (the re-growth of cells at the treated site) as compared to the control stent.

Stents are designed to treat blockages in arteries by propping open the occluded portion of the artery. The addition of a therapeutic agent to the stent is being developed as a means of reducing restenosis, the longer-term re-growth that can block a treated artery. Guidant's PHARMA-LINK Program offers drug-eluting capability on Guidant's latest stent platform. Developed to be a complete system for treating coronary blockages, the stent system includes a proprietary coating consisting of a timed-release polymer containing Actinomycin D, an antineoplastic drug developed by Merck & Company. Guidant's drug eluting stent system is currently in the research and development phase and Guidant expects to begin human clinical studies with this stent in the second quarter of 2001.

"We have seen histologic evidence with Guidant's drug eluting stent that shows a dose response and healing, including early endothelialization in a porcine model," said Renu Virmani, M.D., of the Armed Forces Pathology Institute in Washington, D.C. Dr. Virmani is one of the physicians participating in pre-clinical studies on Guidant's PHARMA-LINK Stent Program. "These results support moving ahead into clinical evaluation of this new, exciting therapy."

Guidant's PHARMA-LINK Stent Program features:

• A timed-release polymer drug delivery system that is designed for extended release of Actinomycin D after the stent is implanted in the patient's artery. Guidant has developed proprietary technologies to tailor the drug's dose and release rate, which will allow the company to optimize the therapeutic benefits of the treatment.

• A stent system that features Guidant's latest coronary stent platform, the MULTI-LINK TETRA(tm), and proprietary delivery technology. This stent system was designed for exceptional deliverability and to offer the highest levels of four key design attributes in a single system - scaffolding, flexibility, conformability and visibility. The MULTI-LINK TETRA is currently the leading coronary stent system worldwide.

"We are encouraged by the positive results from these pre-clinical studies on the PHARMA-LINK Stent Program," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "Many elements are important to the success of a drug eluting stent system, including the drug, its dosing and release profile, and the stent design and the stent delivery system. We are confident that future studies will help demonstrate that our drug eluting stent is a viable treatment for restenosis. With over 1.5 million Guidant coronary stents implanted worldwide, we are excited to be taking this step forward in advancing therapy for coronary artery disease."

"Guidant has an extensive history in drug delivery stent research, including the development of several core technologies in this emerging field," said Richard Stack, M.D., of Duke University in Durham, N.C. "Drug eluting stents have the potential to revolutionize the treatment of cardiac and vascular disease and I am very excited about Guidant's progress toward this goal."

In addition to Guidant's existing interventional cardiology products, the company filed with the U.S. Food and Drug Administration for approval of its GALILEO(tm) Intravascular Radiotherapy System in December 2000. Already approved in Europe and in other countries that base regulatory approval for medical devices on the European CE Mark, the GALILEO System is designed to reduce the reoccurrence of blockages in coronary arteries with a small dose of beta radiation administered through a catheter-based system.

Ronald W. Dollens, Guidant president and chief executive officer, will speak about Guidant's PHARMA-LINK Stent program at the Merrill Lynch Global Health Care Conference in New York on Feb. 6. Dollens is scheduled to provide a presentation on Guidant's business at 10:10 a.m. (EST). Interested parties may access the live webcast of Guidant's presentation through Guidant's website or at the Merrill Lynch website. The webcast will be archived on both websites for future on-demand replay.

System requirements for the webcast include Internet Explorer 5.0 (or higher) or Netscape Navigator 4.0 (or higher). Users also should have the most recent version of Windows Media Player, which can be downloaded for free. Users may experience varying levels of performance based on their connection speed, system capabilities and presence of a corporate firewall. To ensure a connection, users should go to the program five to 15 minutes before its start.

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.