May 9, 2000
Guidant Corporation Announces CE Mark and Launch of its GALILEO System, A Beta-Radiation Treatment for Coronary Artery Disease
Indianapolis, IN and Santa Clara, CA - Patients suffering from re-occurring blockages in coronary arteries can now look forward to a new technology that has been shown to reduce the recurrence of further blockages. Guidant Corporation (NYSE and PCX: GDT) announced that its GALILEO(tm) Intravascular Radiotherapy System - a fully automated treatment designed to reduce or minimize re-occurring blockages - has received CE Mark approval, and is now available for commercial use in most European countries and in others that base regulatory clearance on the European CE mark. Guidant is a world-market leader in the treatment of coronary artery disease with its coronary stents and stent delivery systems. Re-occurring blockages of coronary arteries, known as restenosis, is caused by excessive cell proliferation in treated coronary arteries. It is one of the biggest challenges in cardiovascular medicine today. Recent clinical trials to date have indicated that radiation applied in conjunction with balloon angioplasty and/or stenting can significantly reduce restenosis by stopping excessive cell proliferation within the artery. Intravascular radiotherapy has been shown to be effective in allowing a significant number of patients to avoid repeated interventions and, in some cases, coronary bypass surgery. The GALILEO System is the first commercially available intravascular radiotherapy system to offer the following unique features: The system is comprised of three components: a centering catheter, a source wire and a source delivery unit. Following angioplasty and/or stenting, 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 ranging on average from three to five minutes. The source wire is then automatically retracted back into the source delivery unit to complete the procedure. "I have already treated a number of patients in clinical trials with Guidant''s intravascular radiation system," said Dr. Albert Raizner, director of cardiac catheterization laboratories at Methodist Hospital in Houston, the primary investigator for Guidant''s PREVENT clinical trial. "Many of those patients would have required coronary bypass surgery had Guidant''s radiotherapy system not been available." More than 1.5 million people worldwide undergo coronary angioplasty and related procedures each year. However, 30-50 percent of patients experience re-blockages within six months of their initial procedure. Coronary stents, which are tiny metal tubes that function as scaffolding to hold previously blocked arteries open, have been greatly successful in reducing restenosis. This condition, however, still develops in approximately 20 percent of patients implanted with stents. Analysts estimate that the total world market for radiotherapy will eventually exceed $1 billion annually. "Guidant''s radiation program is entering an exciting new phase as we launch the GALILEO System internationally," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "We believe that the application of radiation will be highly effective in reducing the occurrence of restenosis for patients suffering from coronary artery disease. In addition to producing innovative therapies, we are committed to increasing the collective body of knowledge about this emerging field to ensure that the use of radiation in the treatment of cardiovascular disease is precise, simple, and most importantly, safe for physicians and their patients." Guidant conducted PREVENT (Proliferation REduction with Vascular ENergy Trial), a randomized, prospective clinical trial with 108 patients to assess the performance of its intravascular radiation system in treating both first-time and re-occurring blockages of coronary arteries. The study was conducted at multiple sites in the United States, Europe and Singapore, generating clinical data leading to Guidant''s CE Mark approval, allowing commercial use of this system outside the U.S. While the GALILEO System has received CE Mark approval, it is currently limited to investigational use in the U.S. "The Guidant System significantly reduced the occurrence of restenosis in the PREVENT trial," said Raizner. "Patients who received radiotherapy had a restenosis rate of 8 percent at the lesion site, while the control patients, who did not receive radiotherapy, had a restenosis rate of 39 percent." In addition to pioneering development of the world''s first fully automated intravascular radiotherapy system, Guidant is also a research leader in studying radiation for the treatment of coronary artery disease. It has devoted substantial resources to developing its radiation program. The company is currently conducting and/or collaborating on four additional radiation-specific clinical trials and has plans to begin four more in the near future. INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial) is currently being conducted to further study the effectiveness of Guidant''s radiotherapy system. This randomized, multi-center trial comprised of 310 patients with in-stent restenosis is being conducted at leading cardiovascular centers throughout the U.S. and internationally. Enrollment was completed in December, 1999. Guidant will file the GALILEO System with the U.S. Food and Drug Administration upon completion of the INHIBIT clinical trial patient follow-up. In conjunction with the international launch of the GALILEO System, Guidant is enrolling patients into 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 (re-occurring) and in-stent restenotic native coronary artery lesions. In addition to the development of its intravascular radiotherapy system, Guidant recently announced that it has begun initial trials of its radiated coronary stent, the ACS MULTI-LINK® Radiation Coronary Stent System, at the Thoraxcentre in Rotterdam, The Netherlands. Guidant is also involved in the development of radiation therapy systems to treat peripheral artery disease, working in collaboration with Nucletron B.V. of The Netherlands on the PARIS (Peripheral Artery Radiation Investigational Study) trial. Nucletron''s afterloader technology was also used by Guidant for the PREVENT trial and Nucletron''s worldwide service organization provides field service for the GALILEO afterloader system. A global leader in the medical device industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.