Guidant Receives Exclusive Expanded Indication for Heart Failure Treatment; Thousands of Additional Patients Now Eligible to Receive Cardiac Resynchronization Therapy Defibrillators.INDIANAPOLIS & ST. PAUL, Minn. -- Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT) today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved an expanded indication for the company's portfolio of cardiac resynchronization therapy defibrillators (CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators ). The expanded indication makes Guidant's cardiac resynchronization therapy defibrillators available to thousands more heart failure patients, helping them live both better and longer. The expanded indication, effective immediately, is based on results from the Comparison of Medical Therapy, Pacing, and Defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. in Heart Failure (COMPANION) Trial, sponsored solely by Guidant. Guidant is the only manufacturer to have its cardiac resynchronization therapy defibrillators indicated for the entire COMPANION heart failure patient population. Guidant cardiac resynchronization therapy defibrillators are now indicated for patients with moderate to severe heart failure (NYHA NYHA New York Heart Association III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (an ejection fraction less than or equal to 35 percent) and QRS QRS A pattern seen in an electrocardiogram that indicates the pulses in a heart beat and their duration. Variations from a normal QRS pattern indicate heart disease. Mentioned in: Bundle Branch Block duration of greater than or equal to 120 milliseconds. Previously, patients were required to be indicated for both an implantable cardioverter defibrillator and resynchronization therapy in order to receive a cardiac resynchronization therapy defibrillator. This expanded indication means heart failure patients no longer need to have an implantable defibrillator indication to receive the benefits of a Guidant cardiac resynchronization therapy defibrillator. "Approval from the FDA to expand indications for Guidant cardiac resynchronization therapy defibrillators further demonstrates the scientific strength of the COMPANION study," said Dr. Joseph Smith, chief medical officer, Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. , Guidant Corporation. "This new indication allows physicians to extend the lifesaving and life-enhancing benefits of CRT-D therapy to a broader group of patients struggling daily with the burdens of moderate to severe heart failure." Heart failure is a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition that affects not only a patient's quality of life, but also life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. Nearly 22 million people worldwide, including approximately 5.5 million Americans, currently suffer from heart failure. Heart failure patients are at significant risk for sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. . On average, about 50 percent of heart failure patients die of lethal arrhythmias, or sudden cardiac death. About Guidant Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Driven by a strong entrepreneurial culture of 12,000 employees, Guidant 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. NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. |
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