Apr 1, 2004
Guidant Announces Completion of Enrollment in SPIRIT FIRST Everolimus Eluting Stent Trial

Important Milestone Achieved in Guidant''s Everolimus Eluting Stent Program; Next-Generation Drug Eluting Stent Utilizes Company''s VISION Cobalt Chromium Stent Technology

Indianapolis, Ind., and Santa Clara - Guidant Corporation (NYSE: GDT) today announced completion of enrollment in SPIRIT FIRST, a clinical trial evaluating Guidant''s second drug eluting stent system for the treatment of coronary artery disease. The 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.

"This important milestone signifies continued progress in our drug eluting stent program. With the SPIRIT FIRST and FUTURE clinical trials, Guidant will be the first company with clinical data on drug eluting stent systems utilizing both durable and bioabsorbable polymers," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "We look forward to presenting the six-month follow-up data from this feasibility study at a scientific meeting by year-end, as planned."

The SPIRIT FIRST study 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 (a measurement of the re-narrowing of the vessel caused by tissue re-growth inside the stent) 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 of the United States.

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 CHAMPIONTM 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 evaluated in the SPIRIT FIRST trial, utilizes a durable polymer.

Bioabsorbable polymers are eventually fully absorbed by the body; durable polymers are not absorbed by the body and remain permanently on the stent after the drug is eluted. 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 the 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.

Two new FUTURE trials are planned: FUTURE III, 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 of the U.S.; and FUTURE IV, 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 of 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.