Mar 30, 2003
Guidant Reports Positive Six-Month Clinical Results of Everolimus Eluting Coronary Stent

Data Supports Use of Everolimus for Drug Eluting Stents

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced positive six-month results for the FUTURE I clinical trial, a prospective, randomized, single-blind trial evaluating the safety of an everolimus eluting coronary stent utilizing a bioabsorbable drug-delivery coating vs. a bare metal stent platform in de novo (previously untreated) lesions.

Six-month angiographic and intravascular ultrasound (IVUS) follow-up were performed on 25 patients who received an everolimus eluting stent and 11 patients treated with a control metallic stent. Both follow-up analyses demonstrated a significant reduction in lesion regrowth within the stent. Angiographic late loss, or the loss of open lumen within the stent, was only 0.1 mm in the everolimus eluting stent group compared to 0.83 mm in the control arm. IVUS follow-up demonstrated that patients who received the everolimus-eluting stent had a statistically significant reduction in percent neointimal volume (a measure of tissue regrowth within the stent) at six months after implantation, compared to the control group. No angiographic in-stent binary restenosis was observed in the everolimus eluting stent arm.

"These positive preliminary six-month results further validate our enthusiasm about everolimus as a compound for drug eluting stents. We are excited about the potential of utilizing everolimus with Guidant''s multiple stent platforms and multiple polymers, including bioabsorbable formulations," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "We look forward to working with Dr. Grube and the other investigators to ensure completion of follow-up and analysis of the FUTURE II European clinical trial which utilized the same everolimus-eluting stent in a broader patient group."

"These clinical results demonstrate the promise of everolimus as a potent inhibitor of vascular restenosis," said Dr. Eberhard Grube of the Herzzentrum Siegburg in Germany, principal investigator of FUTURE I, who presented the results yesterday at a scientific symposium sponsored by the Cardiovascular Research Foundation of New York held prior to the American College of Cardiology meeting in Chicago. "We will complete the analysis of FUTURE I shortly, and begin follow-up on patients enrolled in FUTURE II."

Dr. Alexandra J. Lansky, director, Angiographic Core Laboratory, Cardiovascular Research Foundation, New York, provided the quantitative angiographic results. Additionally, the Stanford University Cardiovascular Core Analysis Laboratory at Palo Alto, California provided analysis of the coronary ultrasound images obtained in the trial. Dr. Peter Fitzgerald, Associate Professor of Cardiovascular Medicine, and co-director of the Center for Research in Cardiovascular Interventions and director of the Cardiovascular Core Analysis Laboratory will present additional results from the IVUS analysis of FUTURE I patients during the American College of Cardiology meeting.

Guidant announced on March 19 that the company had entered into a definitive agreement to acquire certain assets of Biosensors International''s everolimus eluting stent program, including the FUTURE I and FUTURE II clinical trials. The agreement provides an exclusive worldwide license to Biosensors'' bioabsorbable polymer formulation technology in the field of everolimus eluting stents. Guidant also obtained a nonexclusive license to utilize this technology with other drugs in drug eluting stents. Additionally, Guidant acquired the option of manufacturing and commercializing the Biosensors everolimus eluting stent that has been used in Biosensors'' clinical trials. Guidant previously entered into an agreement with Novartis Pharma AG and Novartis AG that provides Guidant an exclusive worldwide license to use everolimus in drug eluting stents.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 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. For more information visit www.guidant.com.

NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company''s newsroom at www.guidant.com/newsroom.

This release includes forward-looking statements concerning anticipated financial results. The statements are based on assumptions about many important factors, including trends affecting ICD and coronary stent sales (including the introduction of drug-eluting stents); other clinical, regulatory, competitive, and market developments; reporting of final, audited results; and other factors identified on Exhibit 99.1 to the company''s most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.