First Patients Treated With Guidant's Drug-Eluting Stent; Clinical Trial Will Be Basis for CE Mark Approval of MULTI-LINK TETRA-D Stent

Business Wire, May 24, 2001

Business Editors and Health/Medical Writers

INDIANAPOLIS, Ind. and SANTA CLARA, Calif.--(BW HealthWire)-- May 24, 2001

Guidant Corporation (NYSE:GDT) (PCX:GDT), a world leader in the treatment of coronary artery disease, today announced that the first patients have been enrolled in the company's ACTION (ACTinomycin Eluting Stent Improves Outcomes by Reducing Neointimal Hyperplasia) study supporting the PHARMA-LINK(TM) Drug Eluting Stent Program. The first clinical trial patients treated in this initial study were implanted with the MULTI-LINK TETRA-D(TM) Drug Eluting Stent. This stent is designed to reduce the rate of re-blockages in coronary arteries, and features Guidant's market leading MULTI-LINK TETRA(TM) stent platform with T.R.U.E. Coat(TM) polymer, a timed-release polymer designed for release of a therapeutic drug to a targeted treatment site.

"Bare metal stents have been successful in treating coronary artery disease, but in one out of every five stent cases, the arteries re-clog around the stents," said Professor Patrick Serruys, M.D., of Erasmus University and the Thoraxcentre Hospital in Rotterdam, the Netherlands. "Guidant's drug eluting stent is designed to inhibit the formation of these re-blockages as the stent's polymer coating delivers controlled quantities of an antiproliferative drug at the treatment site."

Marie Claude Morice, M.D., of the Institut Jacques Cartier in Massy, France, as well as Professor Serruys, implanted the first patients with the MULTI-LINK TETRA-D Drug Eluting Stent during live cases that were broadcast to attendees of the Paris Course on Revascularization, a major annual medical meeting of international cardiologists.

Drug Eluting Stent Program Continues Progressing Rapidly

"Performing the first human implant is a significant milestone for Guidant's drug eluting stent program, and illustrates our rapid progress in this emerging field," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "We are excited about beginning this meaningful study and believe this new therapy holds exceptional promise in treating patients with heart disease and combating restenosis."

The ACTION trial will be Guidant's pivotal drug eluting stent trial to gain CE Mark approval of the MULTI-LINK TETRA-D Drug Eluting Stent System. The company also plans to use the ACTION trial as the basis for its submission of an investigational device exemption (IDE) with the U.S. Food and Drug Administration (FDA).

Earlier this year, Guidant announced that pre-clinical tests on its drug eluting stent showed a marked reduction in the growth of cells at the site of the drug eluting stent in comparison to stent placement without a drug.

"Guidant's pre-clinical tests evaluated a variety of doses," said Renu Virmani, M.D., of the Armed Forces Pathology Institute in Washington, D.C., one of the physicians who participated in pre-clinical studies on Guidant's drug eluting stent. "These doses demonstrated a dose-dependent effectiveness and early vessel healing, enabling Guidant to move forward into human clinical trials."

Clinical Trial to Study Important Therapeutic Challenge

Professor Serruys will serve as principal investigator for Guidant's randomized ACTION study to evaluate Guidant's drug eluting stent in patients with first-time blockages in native coronary arteries. This study will treat over 350 randomized patients at 25 centers in Europe, Australia and New Zealand. Patient enrollment in this trial is expected to be complete in 90 days.

The ACTION trial will evaluate a potential solution to a serious clinical challenge - restenosis - or re-blockages that form in coronary arteries following treatment with angioplasty or traditional coronary stents. Between 30 and 50 percent of coronary artery disease patients who receive treatment with angioplasty return to their physicians with re-blockages in the treated artery. Although traditional coronary stents have lowered these rates, up to 20 percent of stent patients return to the hospital with re-blockages.

About Guidant's Drug Eluting Stent Program

Guidant's PHARMA-LINK Stent Program offers drug-eluting capability on Guidant's latest stent platforms. Developed to be a complete system for treating coronary blockages, the stent system features:

-- T.R.U.E. Coat(TM) polymer, a timed-release polymer drug delivery system that
is designed for extended release of Actinomycin D - an antiproliferative drug
developed by Merck & Company - after the stent is implanted in the patient's
artery. Guidant has the ability to precisely tailor the drug's dose and release
rate, which will allow the company to optimize the therapeutic benefits of the
treatment.

-- Processes to ensure uniform coating of the polymer drug delivery system
across the stent for better consistency in treating the coronary blockage.

-- A stent system that features Guidant's MULTI-LINK TETRA(TM) coronary stent
platform, and proprietary delivery technology. This stent system was designed
for excellent deliverability and incorporates four key design attributes in a
single system

-- scaffolding, flexibility, conformability and visibility.

-- A stent system created with innovative manufacturing processes that were
developed to maintain the same level of performance in Guidant's drug eluting
stents as Guidant's traditional coronary stent systems, in performance areas
such as stent retention.