Dec 8, 2000
Guidant Launches Clinical Trial to Evaluate its Intravascular Radiotherapy System in Treating Long Coronary Lesions
Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced the enrollment of the first patient in a clinical study designed to evaluate the efficacy of its GALILEO(tm) Intravascular Radiotherapy System in treating longer blockages in native coronary arteries. The first LIMIT patient was enrolled by Louis McKeever, M.D., at the Midwest Heart Research Institute in Elmhurst, Ill. The GALILEO System is commercially available in Europe but remains an investigational device in the United States. Recent clinical trials have shown that radiotherapy reduces the incidence of restenosis - re-occurring blockages of coronary arteries-that occurs in up to 50 percent of patients treated with coronary angioplasty. Part of Guidant's comprehensive radiotherapy program, the LIMIT (Long Lesion Intracoronary Radiation to Minimize Intimal Hyperplasia Trial) clinical study will utilize Guidant's beta radiation system to treat coronary blockages up to 47mm in length in up to two native coronary arteries. It is a prospective, randomized, double blinded, placebo-controlled clinical trial. The LIMIT protocol is designed to enroll 360 patients at 40 centers worldwide. The U.S. Food and Drug Administration (FDA) has approved the first stage of the LIMIT trial. "Intravascular radiotherapy appears to be a promising solution for restenosis, which for years has been a significant issue for interventional cardiologists and their patients," said Albert Raizner, M.D., director of cardiac catheterization laboratories at Methodist Debakey Heart Center in Houston, Texas, who is serving as principal investigator of the LIMIT trial. "The LIMIT trial is designed to examine the ability of Guidant's beta radiation system to treat restenosis in long, diffuse (extensive) coronary lesions. Typically, patients with such lesions have an extremely high risk of restenosis with conventional treatment." Long, diffuse coronary lesions have a significantly greater risk of restenosis than shorter, focal lesions. The LIMIT trial will evaluate the ability of beta radiation to treat long, diffuse lesions, and is the first clinical study utilizing coronary intravascular radiotherapy that will allow physicians to treat more than one coronary artery with intravascular radiation. "Data from our INHIBIT clinical trial recently proved what Guidant has believed for some time: that intravascular radiotherapy reduces the rates of restenosis for patients suffering from coronary artery disease," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "We also learned that patients treated with radiotherapy have increased rates of event-free survival, which should come as positive news for patients and physicians alike." Results from the INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial) trial were presented in November 2000 at the 73rd Scientific Sessions of the American Heart Association in New Orleans. The trial was designed to evaluate Guidant's beta radiation system for the treatment of in-stent restenosis in native coronary arteries with diameters from 2.4 to 3.7 mm and a maximum treated length less than 47 mm. The prospective, double blinded, multi-center randomized trial enrolled 332 patients suffering from coronary artery disease at 27 centers worldwide. Key findings from the INHIBIT trial showed: Guidant's 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. In May 2000, 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. The approval was based on results of the PREVENT (Proliferation REduction with Vascular ENergy Trial) clinical trial, which showed that patients who received radiotherapy had a restenosis rate of 8 percent at the lesion site, compared to a 39 percent restenosis rate for control patients who did not receive radiotherapy. In conjunction with the international launch of the GALILEO System, Guidant is currently enrolling patients in the VISION (Vascular Intervention Study with IONizing Radiation) trial. This is a non-randomized evaluation of the GALILEO System in the treatment of patients with de novo (first time), restenotic and in-stent restenotic native coronary artery 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.