Dec 17, 2003
Guidant Announces First Implant in SPIRIT FIRST Drug Eluting Stent Trial

Next-Generation Drug Eluting Stent Utilizes Guidant''s VISION Cobalt Chromium Stent Technology

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the first human implant in SPIRIT FIRST, a feasibility trial evaluating an everolimus eluting stent system utilizing Guidant''s MULTI-LINK VISION(tm) Coronary Stent System platform and a durable polymer drug carrier versus a control uncoated MULTI-LINK VISION Coronary Stent System.

This prospective, randomized, single-blind study will enroll a total of 60 patients at multiple sites in the Netherlands and Germany. The primary endpoint of the study is in-stent late loss at six months. Prof. Patrick W. Serruys, M.D., of The Thoraxcenter, Erasmus University Hospital, Rotterdam is principal investigator for the SPIRIT FIRST study.

"The first implant of our next-generation everolimus eluting VISION-based stent system is a significant milestone for the company," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "We are enthusiastic about utilizing everolimus with the VISION platform, which has demonstrated excellent acute performance and long-term clinical outcomes."

The proprietary cobalt chromium alloy in the MULTI-LINK VISION Coronary Stent System allows for thinner struts and a low profile, which enhances deliverability of the stent system, helping physicians access challenging coronary blockages. The MULTI-LINK VISION Coronary Stent System has demonstrated positive clinical results, with a six-month clinically driven target lesion revascularization (TLR) rate of 1.9 percent.

Results from the FUTURE I and FUTURE II clinical studies demonstrated that an everolimus eluting stent with bioabsorbable polymer was safe, and effective in reducing tissue proliferation following stent implantation. The studies showed a profound effect in reducing binary restenosis with 0 percent (0/46) patients suffering binary restenosis at six-month follow-up, and an 87 percent reduction of in-stent late loss.

About Drug Eluting Stent Polymers

Guidant''s drug eluting stent program utilizes both bioabsorbable and durable polymers. Drug eluting stent polymers have multiple functions: acting as a drug carrier that localizes the drug on the stent during manufacturing; reducing drug contact with blood and enzymes; and controlling the rate at which the drug is released into the vessel. 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 clinical trial name. The company''s clinical trials utilizing durable polymer technology are identified by the SPIRIT designation in the study name.

About Guidant''s Drug Eluting Stent Program

Guidant anticipates introducing its first everolimus eluting stent, the CHAMPION(tm) Drug Eluting Stent System, in Europe in the first quarter of 2005 and in the United States in the first quarter of 2006. The CHAMPION Drug Eluting Stent System utilizes a bioabsorbable polymer on a stainless steel stent platform with the VISION delivery system. During its Nov. 19 Investor/Analyst Conference, the company announced plans for two new clinical trials of the CHAMPION Drug Eluting Stent System: FUTURE III, an 800-patient clinical study that will provide additional safety and performance data to support market launch of the CHAMPION Drug Eluting Stent System outside of the United States, and FUTURE IV, a 975-patient U.S. pivotal trial that will support FDA approval of the product.

Guidant''s next-generation, VISION-based drug eluting stent system evaluated in the SPIRIT FIRST trial utilizes a durable polymer. Guidant is also developing a VISION-based drug eluting stent that utilizes a bioabsorbable polymer. The company expects to launch a VISION-based drug eluting stent system in Europe in mid-2006 and in the United States in late 2006.

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.

This release includes forward-looking statements concerning development timelines for and the competitiveness of the company''s drug eluting stents. The statements are based on assumptions about many important factors, including regulatory timelines, satisfactory clinical results, other clinical factors, such as speed of trial enrollment, any litigation or competitive developments, 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 its forward-looking statements.