Dec 19, 2000
Guidant Files for FDA Approval of its GALILEO Intravascular Radiotherapy System

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, announced today that is has filed with the U.S. Food and Drug Administration (FDA) for its GALILEO(tm) Intravascular Radiotherapy System. Already approved in Europe, the GALILEO System is designed to prevent the reoccurrence of blockages in coronary arteries.

Guidant's investigational GALILEO Intravascular Radiotherapy System, which is fully automated and utilizes beta radiation, is a three-component system consisting of a centering catheter, source wire and source delivery unit. Following angioplasty, the physician advances the centering catheter through the artery until it reaches the treatment area. The source delivery unit automatically advances the source wire, containing the radioisotope Phosphorus 32 (32P), through the centering catheter to the diseased coronary artery. An automatically calculated, precise dose of beta radiation is then delivered to that exact area for a predetermined period of time. The source wire is then automatically retracted back into the source delivery unit to complete the procedure.

"We are very pleased with our progress in the emerging radiotherapy field," commented John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "Based on the positive results from both the PREVENT and INHIBIT radiotherapy clinical trials, Guidant is excited about the prospect of making this therapy available to physicians in the U.S. and their patients suffering from coronary artery disease."

In November, results from the INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial) trial were presented at the 73rd Scientific Sessions of the American Heart Association in New Orleans, by Dr. Ron Waksman, primary investigator for this trial. The 332-patient, prospective, double-blinded, multi-center randomized trial was designed to evaluate Guidant's beta radiation system for the treatment of stainless steel in-stent restenosis in native coronary arteries.

Key findings from the INHIBIT trial showed:

• Recurrent restenosis rates in the stented area of the artery for patients treated with radiotherapy were 67 percent lower than patients in the control group, with a recurrent restenosis rate of 16 percent for radiotherapy patients as compared to 49 percent for patients in the control group.

• The incidence of the primary endpoint of major adverse cardiac event (MACE, a composite of death, myocardial infarction and repeat revascularization of the target site) among radiotherapy patients at nine months was 56 percent lower than patients in the control group. Data from radiotherapy patients show a MACE rate of 14 percent, as compared to 31 percent for the control group.

Earlier this year, 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. The prospective, randomized, blinded, multi-center study enrolled patients who had been previously treated with coronary angioplasty or implanted with a coronary stent.

Guidant recently launched the LIMIT (Long Lesion Intracoronary Radiation to Minimize Intimal Hyperplasia Trial) clinical study, which will utilize Guidant's GALILEO System to treat coronary blockages up to 47mm in length. It is a prospective, randomized, double-blinded, placebo-controlled clinical trial.

In May, Guidant received CE Mark approval for its GALILEO Intravascular Radiotherapy System, making the system available in Europe and in other countries that base regulatory approval for medical devices on the European CE Mark.

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.