Mar 26, 2001
Guidant's Intravascular Radiotherapy System Enjoys Continued Success in Europe

Company Satisfies European Post-Marketing Requirements for its GALILEO System

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced that it has enrolled 100 patients in its VISION (Vascular Intervention Study with IONizing Radiation) trial. Reaching this milestone satisfies European post-marketing requirements. The VISION trial is a non-randomized evaluation of Guidant's GALILEO(tm) Intravascular Radiotherapy System for use in treating first-time blockages, re-occurring blockages and blockages that occur inside of a stent.

"Achieving the first milestone in the VISION trial is vital to gathering follow-up clinical data on radiotherapy for treatment of coronary artery disease," commented Professor Wolfgang Rutsch, M.D. of University Clinic Charite in Berlin, Germany, who is serving as principal investigator of the VISION trial. "Monitoring long-term results will provide important insights into this new, promising treatment option."

Adoption of the GALILEO System in Europe is Brisk

Guidant's GALILEO System, currently an investigational device in the U.S., is designed to reduce the number of repeat angioplasty and stent procedures by delivering a precise dose of radiation to the exact site of a coronary blockage. Since receiving CE Mark approval last year, many leading European institutions throughout 11 countries - including Germany, the UK and Spain - have begun using the GALILEO System to treat patients with coronary artery disease. In addition, over 400 clinicians have received training on Guidant's radiotherapy system, 175 of which were trained at the state-of-the-art Guidant European Cardiovascular Institute. Located in Brussels, Belgium, this cardiovascular facility employs a faculty of world-class experts to train practitioners in new and emerging therapies for the treatment of cardiovascular disease.

"There is a significant need for intravascular radiotherapy and we are very encouraged by Guidant's initial success in the European market," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention group. "As a leader in the development of new solutions for treating cardiovascular disease, we are pleased to see that our GALILEO System is becoming a viable treatment option."

Clinical Data Shows GALILEO System Reduces Rates of Restenosis

Clinical trials to date have shown that small amounts of radiation applied to blocked coronary arteries appear to stop cell growth that can cause re-blockages to form in previously treated arteries. Results from the PREVENT CE (Proliferation REduction with Vascular ENergy Trial) clinical trial showed that patients who received radiotherapy had a restenosis rate of 8.6 percent at the lesion site, compared to a 40.9 percent restenosis rate for control patients who did not receive radiotherapy. This randomized, multi-center study enrolled patients who had been previously treated with coronary angioplasty or implanted with a coronary stent, as well as patients with first time blockages. Guidant utilized data from this trial to file for CE Mark approval of the GALILEO System.

Results from a subsequent radiotherapy trial, INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial), showed a recurrent restenosis rate of 19 percent for radiotherapy patients as compared to 50 percent for patients in the control group. The INHIBIT trial was a randomized, multi-center study that enrolled patients who required treatment for in-stent restenosis in native coronary arteries.

"The clinical data is strong, and clearly supports the use of Guidant's GALILEO System for treating blockages in coronary arteries," said Manel Sabate, M.D., of Hospital Clinico San Carlos in Madrid, Spain. Sabate's hospital was the first site in Spain to use the GALILEO System. "The GALILEO System is a user-friendly system and has the ability to treat challenging cases in a variety of coronary lesions."

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.