Aug 23, 2001
Guidant Introduces Next Generation Radiotherapy System Outside of the United States
Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT) announced today that it has received European CE Mark approval of its next generation radiotherapy system. This is Guidant's second radiotherapy system designed to reduce the incidence of restenosis-re-blockages that form in previously treated coronary arteries. The device is called the GALILEO(tm) 40/60 Automated Intravascular Radiotherapy System. "Guidant is committed to providing our physicians and their patients with the most advanced intravascular radiotherapy technology possible," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The international launch of our next generation radiotherapy system is consistent with Guidant's commitment to deliver to the market a comprehensive line of vascular intervention products for treating a spectrum of clinical needs." As announced earlier this week, Guidant broadened its drug-coated stent program by entering into a worldwide distributor agreement for a new paclitaxel-coated coronary stent to be developed and manufactured by COOK. Guidant is also progressing in its ACTION trial, a randomized study evaluating Guidant's internally developed drug-coated stent systems as potential means of reducing restenosis. In addition, Guidant offers a broad range of coronary stent systems for treating coronary artery disease that include a broad-use system, the MULTI-LINK PENTA(tm) Coronary Stent System and a system designed specifically for smaller diameter vessels with abrupt or threatened abrupt closure, the MULTI-LINK PIXEL(tm) Coronary Stent System. The original GALILEO System was approved last year under the European CE Mark and in countries recognizing this approval. Guidant has filed for U.S. Food and Drug Administration (FDA) approval of the GALILEO System and anticipates launching this product in the U.S. later this year. Guidant's next generation radiotherapy system received CE Mark approval for treating longer coronary artery segments with an equivalent source length of up to 60 mm and smaller reference lumen diameter arteries as small as 2.4 mm. Patients with this type of coronary artery disease are generally prone to higher rates of restenosis. "Guidant's next generation radiotherapy system is an important development in the treatment of patients with coronary artery disease," said Ron Waksman, M.D., director of experimental angioplasty and vascular brachytherapy, Washington Hospital Center in Washington, D.C. "In addition to its ability to treat longer lesions in coronary arteries, this new automated system will also enable physicians to more easily perform the radiotherapy procedure by automatically determining the number of steps required to treat a particular lesion and automatically performing those steps." "The introduction of Guidant's new radiotherapy system is exciting for physicians with patients suffering from difficult-to-treat conditions like restenosis," added Professor Helmut Dietmar Glogar, M.D., of University Hospital of Vienna in Vienna, Austria. "The system's ability to treat longer lesions enables this treatment to be applicable to a greater number of patients with coronary artery disease." Since Guidant's first intravascular radiotherapy system was introduced into the European market 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. Over 400 clinicians have received training on Guidant's radiotherapy system, with approximately one half trained at the state-of-the-art Guidant European Cardiovascular Institute. Located in Brussels, Belgium, Guidant's cardiovascular facility employs a faculty of world-class experts to train practitioners in new and emerging therapies for the treatment of cardiovascular disease. In addition, Guidant has seen the number of European patients treated with its radiotherapy system double in the second quarter of 2001, compared to the first quarter of this year. Like its predecessor, Guidant's next-generation intravascular radiotherapy system is designed to reduce re-blockages in coronary arteries by applying a small dose of beta radiation to the artery. The GALILEO 40/60 Automated System is composed of three components: Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.About Guidant's Next Generation Intravascular Radiotherapy System