May 26, 2004
Guidant Reports Positive Results from Two Everolimus Eluting Coronary Stent Trials

SPIRIT FIRST 30-Day and FUTURE II One-Year Results Continue to Support Benefit of Everolimus Eluting Coronary Stents

Indianapolis, Ind., and Paris - Guidant Corporation (NYSE: GDT) today announced results from two clinical trials evaluating everolimus eluting stents. Twelve-month results from the FUTURE II clinical trial will be reviewed by Beverly Lorell, M.D., Guidant vice president and chief medical and technology officer, during the company''s mid-quarter conference call tomorrow, Thursday, May 27, at 9:00 a.m. EDT. Thirty-day results from the SPIRIT FIRST feasibility study evaluating Guidant''s MULTI-LINK VISION® Coronary Stent System-based drug eluting stent system for the treatment of coronary artery disease were presented by Jan J. Piek, M.D., of the Academic Medical Center, Department of Cardiology, University of Amsterdam, today at the Paris Course on Revascularization (EuroPCR) conference taking place through Friday, May 28.

The FUTURE II clinical trial compares an everolimus eluting coronary stent system that utilizes a bioabsorbable polymer versus an uncoated metallic stent control in de novo (previously untreated) lesions in native coronary arteries. Both the safety and efficacy results from FUTURE II at six months were sustained at 12-month follow-up; no new major adverse cardiac events (MACE) occurred in the everolimus eluting stent arm between the six and 12-month follow up period. Thus, the 4.8 percent MACE rate observed at six months did not change at 12 months. The MACE rate includes any deaths, heart attacks or target lesion revascularizations (a measure of the need for repeat intervention at the site of the original stent implantation) within the 12-month period. The multicenter trial evaluated the everolimus eluting stent system in 21 patients; 43 patients received the uncoated metallic stent control.

The SPIRIT FIRST clinical trial compares an everolimus eluting stent system utilizing Guidant''s cobalt chromium MULTI-LINK VISION Coronary Stent System platform with a durable polymer drug carrier, versus an uncoated MULTI-LINK VISION Coronary Stent System control. SPIRIT FIRST reported 30-day MACE rates of 7.1 percent (2 patients of 28) in one arm and 0 percent in the other (0 patients of 32). As defined in SPIRIT FIRST, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the 30-day period. Because the study is blinded, it is not known at this time which group received the everolimus eluting coronary stent and which group received the control stent.

"The results from FUTURE II further support the sustainability of the excellent data on the bioabsorbable everolimus eluting stent platform that we observed with FUTURE I at six and 12 months," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "In addition, the 30-day MACE data from the SPIRIT FIRST study are consistent with historical 30-day MACE rates in drug eluting stents. These results are encouraging and continue to reinforce our confidence in everolimus eluting stents. We look forward to reporting six-month follow-up data from SPIRIT FIRST later this year."

Guidant''s Drug Eluting Stent Program

Guidant has been a global innovator in stent technology since 1995, when its first coronary stent for the treatment of heart disease was launched internationally. Since then, the company has consistently been the market leader in metallic stent sales worldwide. Guidant''s drug eluting stent program leverages this market-leading position as well as the company''s excellent customer relationships built through its world-class sales force. The company''s vascular intervention business is focused on developing broad capabilities in drug eluting stents, including product design, clinical science, polymer science and product commercialization. Guidant holds a worldwide exclusive license from Novartis Pharma AG to use everolimus, a novel proliferation-signal inhibitor with potent anti-proliferative and immunosuppressant properties, in drug eluting stents. Guidant has both durable and bioabsorbable polymer drug carriers in development, providing product design flexibility and potentially offering unique clinical benefits.

Guidant gained immediate entry into the U.S. drug eluting stent market in February through an agreement with Cordis Corporation, a Johnson & Johnson company. Under the terms of the agreement, Guidant co-promotes Cordis'' CYPHER(tm) Sirolimus-eluting Coronary Stent in the United States.

Guidant''s first everolimus eluting coronary stent, the CHAMPION(tm) Everolimus Eluting Stent System, utilizes a bioabsorbable polymer on a stainless steel stent platform with Guidant''s MULTI-LINK VISION® Delivery System. Guidant''s second everolimus eluting coronary stent, the cobalt chromium MULTI-LINK VISION-based stent system currently being evaluated in the SPIRIT FIRST trial, utilizes a durable polymer.

Guidant''s clinical trials employing bioabsorbable polymer technology utilize the FUTURE designation in the study name. The company''s clinical trials utilizing durable polymer technology are identified by the SPIRIT designation in the study name.

The FUTURE Clinical Trials

FUTURE I and FUTURE II evaluated safety and performance of an everolimus eluting stent with a bioabsorbable polymer drug carrier and stainless steel stent platform. Results from the FUTURE I and II clinical trials demonstrated safety and efficacy. There was a profound effect in preventing in-stent restenosis (binary angiographic restenosis), with no restenosis at six-month follow-up among patients receiving an everolimus eluting stent (0/46) and an 87 percent reduction of in-stent late loss compared to a metallic stent control.

FUTURE III is an 800-patient clinical trial that will provide additional safety and performance data to support market launch of the CHAMPION Everolimus Eluting Coronary Stent System outside the United States. Another planned trial, FUTURE IV, is a 975-patient U.S. pivotal trial for the CHAMPION Everolimus Eluting Coronary Stent System.

The SPIRIT Clinical Trials

The initial trial in the SPIRIT series, SPIRIT FIRST, enrolled a total of 60 patients at multiple sites in The Netherlands, Denmark and Germany. The primary endpoint of the study is in-stent late loss at six months. Data from the trial will support filings for both a pivotal trial to obtain approval to market the product in the United States and a larger European study to support market launch outside the United States.

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 more than 12,000 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.

This release includes forward-looking statements concerning the progress of the company''s drug eluting stent program. The statements are based on assumptions about many important factors, including continuing clinical progress with respect to the bioabsorbable and durable polymer programs, the requirements for and timing of any regulatory approvals for the products and other factors identified on Exhibit 99 to the company''s most recent 10-Q. Actual results may differ materially. The company does not undertake to update these forward-looking statements.