Feb 7, 2000
Guidant Announces Start of COMPANION Study Evaluating Treatment of Chronic Heart Failure
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 COMPANION, a multicenter clinical study that will evaluate treatment of patients with chronic heart failure, a cardiovascular disorder affecting a large and growing patient population. The study is being conducted pursuant to an FDA-approved IDE. "COMPANION is designed to help answer important questions associated with the use of implantable devices as new heart failure therapy," according to Jay Graf, president of Guidant''s Cardiac Rhythm Management Group. "Patients will be randomized to receive drug therapy alone or drug therapy in combination with implantable devices that resynchronize heart rhythms." The study will collect and evaluate clinical data on more than 2000 patients in up to 80 centers across the U.S. to help determine the best medical therapy for heart failure patients. Co-principal investigators for the COMPANION trial are Arthur Feldman, M.D., Ph.D., President of the Heart Failure Society of America and Professor of Medicine and Director of the Cardiovascular Institute at the University of Pittsburgh in Pittsburgh, PA, and Michael R. Bristow, M.D., Ph.D., Professor of Cardiology, Department of Cardiology at the University of Colorado, Denver, CO. Criteria that will be evaluated include the following primary clinical endpoints: Products to be evaluated in the COMPANION 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. "Our early experience in Europe indicates that the CONTAK/EASYTRAK system can provide clinical benefit in the treatment of patients who suffer from chronic heart failure," Graf noted. "These device systems offer the potential to relieve symptoms and positively impact the lives of heart failure patients who at this time have few alternatives." Guidant''s heart failure treatment systems were market released in Europe in November 1999. The first implant in the COMPANION trial took place in a 75-year-old male at United Hospital in St. Paul, MN. Doctors Stewart Adler and Greg Granrud participated in the implant procedure which included the CONTAK TR device and EASYTRAK lead manufactured by Guidant. Chronic 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 well over 5 million people in the United States and an estimated 6.5 million in Europe. Nearly one million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder. Chronic 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.