Sep 17, 2003
Guidant Reports Positive Results of Two Everolimus Eluting Coronary Stent Clinical Trials

FUTURE I and II Trials Utilize Everolimus with Bioabsorbable Polymer; Results Presented Today

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT), a world leader in the treatment of cardiac and vascular disease, today reported positive results from two clinical trials evaluating an everolimus eluting coronary stent with a bioabsorbable polymer vs. a metallic stent platform in de novo (previously untreated) lesions in native coronary arteries. Findings were presented at the 15th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C.

Results from the two trials show that the everolimus eluting stent with bioabsorbable polymer was safe, and effective in reducing tissue proliferation in the stent following implantation.

"Everolimus continues to demonstrate considerable promise as a compound for drug eluting stents. These positive results add to our confidence in this drug-and-bioabsorbable polymer combination as a treatment for coronary artery disease," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "Guidant will leverage these data as we move forward with regulatory filings and subsequent clinical studies. We look forward to bringing everolimus eluting stents to patients and physicians through our multiple-technology, multiple-polymer drug eluting stent program."
FUTURE II Six-Month Safety and Efficacy Results Confirm FUTURE I Data

Fully adjudicated results reported from six-month follow-up of FUTURE II, a prospective, randomized, multi-center double-blinded trial of a bioabsorbable polymer and everolimus eluting stent in 21 patients, confirmed the six-month results of the FUTURE I clinical trials presented earlier this year. FUTURE II, which included a more complex patient group than FUTURE I, met its primary safety endpoint, with a 4.8 percent major adverse cardiac events (MACE) rate in the everolimus eluting stent arm at six months. Angiographic endpoint results were positive, with zero percent [0/21] in-stent restenosis (re-narrowing) in the everolimus arm vs. 19.4 percent [7/36] in the metallic control arm. The everolimus eluting stent significantly reduced in-stent tissue proliferation compared to control with a late loss of 0.12 mm.
Preliminary 12-Month Results for FUTURE I Show Sustained Safety and Efficacy

The company also presented preliminary 12-month clinical follow-up for the FUTURE I clinical trial, a prospective, randomized, single-blinded trial evaluating the safety of an everolimus eluting stent in 27 patients. Both the safety and efficacy results from FUTURE I at six months were sustained at 12-month follow-up. Twenty-four patients who had received the everolimus eluting stent were evaluated at 12 months. No new MACE occurred between six and 12 months, with no incidence of repeat intervention required. Preliminary angiographic analysis of eight patients showed no new binary restenosis events. In six patients who underwent follow-up intravascular ultrasound (IVUS), the results were consistent with six-month results demonstrating minimal re-narrowing of the artery (luminal volume obstruction).

"The results from both of these clinical studies provide early evidence of the safety and efficacy of the bioabsorbable everolimus eluting stent platform," said Dr. Eberhard Grube of the Herzzentrum Siegburg in Germany, principal investigator of the FUTURE I and II clinical trials. "I eagerly anticipate the opportunity to participate in further studies with this technology utilizing Guidant''s CHAMPION(tm) drug eluting stent system."

In August 2003 Guidant submitted the first module of the application for CE Mark approval to European regulatory authorities to support approval of Guidant''s CHAMPION drug eluting stent system with a bioabsorbable polymer and everolimus. The submission included the positive six-month data from the FUTURE I clinical trial.

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 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.