Apr 5, 2004
Guidant Announces Enrollment of First Patient in FUTURE III Clinical Trial in Europe

Everolimus Eluting Stent Trial Will Provide Additional Safety and Performance Data

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE: GDT) today announced that the first patient has been enrolled in FUTURE III, an 800-patient clinical trial that will provide additional safety and performance data to support market launch of Guidant''s investigational CHAMPION(tm) Everolimus Eluting Coronary Stent System outside the United States.

"The initiation of FUTURE III is a significant milestone for Guidant''s drug eluting stent program and will provide a deeper understanding of the benefits of everolimus eluting stents for the treatment of coronary artery disease," said Dana G. Mead, Jr., president, Guidant Vascular Intervention. "The start of this new trial demonstrates our confidence in the clinical performance of the CHAMPION Stent System and in our drug eluting stent operational capabilities. We expect that the data from FUTURE III will build upon the excellent results from the FUTURE I and FUTURE II clinical trials, which we anticipate will serve as the clinical basis for regulatory approval in Europe."

FUTURE III is a randomized clinical trial comparing the CHAMPION Everolimus Eluting Coronary Stent System to Guidant''s MULTI-LINK ZETA® Coronary Stent System at approximately 90 sites in Europe, the Middle East, Asia, Australia, Canada and New Zealand. The primary endpoint of the trial is in-segment late loss (a measurement of the re-narrowing of the vessel caused by tissue re-growth in the area of the artery in which the stent was placed) at four, six and 12 months following stent implantation.

The trial is designed to show superiority of the CHAMPION Everolimus Eluting Coronary Stent System, which approximately 600 patients will receive, over the MULTI-LINK ZETA Coronary Stent System, which approximately 200 patients will receive. The company expects to present 30-day MACE (major adverse cardiac event) data from the first 120 patients enrolled in FUTURE III before the end of 2004.

Dr. Ulrich Gerckens performed the first implant at the Herzzentrum Siegburg in Germany. Prof. Eberhard Grube, also of the Herzzentrum Siegburg, is the principal investigator of FUTURE III. "The CHAMPION Stent System is a very competitive drug eluting stent system. I look forward to presenting the results from FUTURE III. The study will provide significant data on the use of the bioabsorbable polymer," said Prof. Grube.

Guidant plans to file the third and final module of its submission for Conformité Européenne (CE) Mark approval during the second quarter. The company expects to launch the CHAMPION Everolimus Eluting Coronary Stent System in Europe in the first quarter of 2005, pending regulatory approvals.

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. Like everolimus, sirolimus has been shown to prevent cellular proliferation and reduce restenosis.

Guidant''s first everolimus eluting stent, the CHAMPION Everolimus Eluting Coronary 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 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 currently enrolling patients that will provide additional safety and performance data to support market launch of the CHAMPION Everolimus Eluting Stent System outside the United States. Another planned trial, FUTURE IV, is a 975-patient U.S. pivotal trial for the CHAMPION Everolimus Eluting 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 is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant 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.