Sep 24, 2002
Guidant Launches Next-Generation Radiotherapy System in the United States

System Designed to Enable Physicians to Treat Long Vessel Blockages With Ease and Precision

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced U.S. Food and Drug Administration (FDA) approval and launch of the company''s next-generation GALILEO® III Intravascular Radiotherapy System for the treatment of coronary artery disease. The system is currently available in Europe.

"Guidant is committed to developing a comprehensive line of technologically innovative products for treating patients with coronary artery disease, and intravascular radiotherapy is a highly advanced therapy for the treatment of in-stent restenosis," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "GALILEO III''s enhanced automaticity is designed to make the system easier to use for clinicians. We are pleased to bring this next-generation radiotherapy system to physicians and patients in the United States."

Intravascular radiotherapy is one of the most effective therapies currently approved in the U.S. for the treatment of in-stent restenosis, the recurrence of a blockage in a coronary artery that has previously been treated with a coronary stent. Restenosis occurs in as many as 20 percent of patients who receive coronary stents each year.

The new GALILEO Intravascular Radiotherapy System features AutoStep(tm) technology, which is intended to provide physicians an easier method to treat long lesions. The system is designed to deliver radiation therapy starting at the distal end of the blockage, automatically stepping the radiation treatment through a catheter to treat the length of the artery needing therapy.

"Guidant''s next-generation radiotherapy system allows physicians to more easily treat a wide range of lesions with a single system, including long lesions," said Alan Yeung, M.D. of the Division of Cardiovascular Medicine, Stanford University, Stanford, Calif. "As demonstrated by the results of the GALILEO INHIBIT trial, GALILEO III is an important development in the treatment of patients with in-stent restenosis."

Guidant''s GALILEO INHIBIT trial showed that GALILEO III contributed to a significant reduction in the incidence of in-stent restenosis. Key findings from GALILEO INHIBIT show a 71 percent reduction in binary restenosis and a 47 percent reduction in the incidence of Major Adverse Cardiac Events (MACE), a composite of death, myocardial infarction and repeat vascularization of the target site, in patients treated with radiotherapy at nine months.

Since the FDA approved Guidant''s original GALILEO System last November, over 2,300 clinicians in the U.S. alone have received training on the system. In addition, Guidant has seen the number of patients treated worldwide with its radiotherapy systems increase by 50 percent in the second quarter of 2002 when compared to the first quarter of this year.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 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.