Apr 25, 2000
Guidant Announces Start of PACMAN Study To Further Evaluate Novel Heart Failure Treatment
Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a worldwide leader in implantable medical device systems, today announced the start of PACMAN, a multicenter European clinical study that will evaluate treatment of patients with chronic heart failure, a cardiovascular disorder affecting a large and growing patient population. "PACMAN is a prospective randomized trial designed to help answer important questions associated with the use of implantable devices for the treatment of heart failure," according to Fred McCoy, president of Guidant''s Cardiac Rhythm Management Group. "Patients will receive our CONTAK TR or CONTAK CD cardiac resynchronization device, depending upon their arrhythmia profile. "This trial complements the COMPANION trial that we started in February," McCoy noted. COMPANION will collect and evaluate clinical data on more than 2000 patients in up to 80 centers across the U.S. "These trials, along with our announcement earlier this month of our option to acquire new technology for the treatment of heart failure from Impulse Dynamics, are clear evidence of Guidant''s commitment to leadership in the development of better therapy for heart failure patients worldwide," McCoy added. The principal investigator for PACMAN is Prof. P. Hanrath at RWTH, Aachen, Germany. PACMAN was designed in close collaboration with an advisory group composed of Prof. Hanrath and Dr. C. Stellbrink at RWTH, Aachen and Prof. H. Klein and Dr. A. Auricchio at the Universitätsklinik Magdeburg, Germany. The PACMAN study will collect and evaluate clinical data on more than 300 patients in up to 50 centers in nine countries in Europe to evaluate the benefits of biventricular stimulation (which is designed to resynchronize the heart by stimulating both ventricles) in patients with heart failure. During the trial, patients will be randomized to receive or not receive resynchronization therapy for six months. At the end of the first six months, resynchroni-zation will be enabled for all patients. Criteria that will be evaluated include the following clinical endpoints: Products to be used in the PACMAN clinical study include Guidant''s CONTAK(tm) CD pulse generator, which provides heart failure, bradycardia and tachyarrhythmia therapies; the CONTAK TR pulse generator, which provides heart failure and bradycardia therapies; and the EASYTRAK(tm) lead, a patented transvenous over-the-wire lead system developed for implantation in the coronary venous system to coordinate stimulation of the left side of the heart with the right side to treat heart failure. The CONTAK system with an EASYTRAK lead is designed to stimulate both of the lower chambers of the heart in a way that enhances the heart''s pumping efficiency. Conventional systems provide pacing to stimulate only the right side of the heart. The proprietary EASYTRAK lead system, designed in conjunction with Guidant''s Vascular Intervention Group, enables transvenous placement, using an over-the-wire system similar to that used in angioplasty procedures. The first implants in the PACMAN trial were performed by Prof. P. Hanrath and Dr. C. Stellbrink at RWTH Aachen, Germany; Dr. P. Defaye at CHRU Michalon, Grenoble, France; Dr. Y. Guyomar at CH Saint Philibert, Lomme, France; and Dr. H. Pürerfellner at KH Elisabethinen, Linz, Austria. Heart failure is a medical condition in which the heart is unable to pump enough blood to meet the metabolic needs of the body. It affects an estimated 6.5 million people in Europe and well over 5 million people in the United States. Nearly 1 million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder. Heart failure is characterized by physical symptoms such as shortness of breath, problems with physical strength and stamina, fatigue, fluid retention and exercise intolerance. Patients often report disruption of their lives and dissatisfaction with their abilities to perform daily activities. A global leader in the medical device industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information on Guidant''s products and services, visit the company''s website at http://www.guidant.com.