Guidant Begins Enrollment in Clinical Trial to Evaluate Innovative Therapy for the Treatment of Atrial Fibrillation; Study Designed to Evaluate the Safety and Efficacy of Surgical Microwave Ablation Technology to Treat Common Heart Arrhythmia.INDIANAPOLIS & SANTA CLARA, Calif. -- Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ) today announced the enrollment of the first patient in a clinical trial designed to study an innovative therapy for the treatment of permanent atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. . The first patient was enrolled in the trial on June 27, 2005, by John Johnkoski, M.D., cardiothoracic cardiothoracic /car·dio·tho·rac·ic/ (-thah-ras´ik) pertaining to the heart and the thorax. car·di·o·tho·rac·ic n. Of or relating to the heart and the chest. surgeon, at Wausau Hospital in Wausau, Wis. Called RESOLVE-AF, (RandomizEd ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Study Of SurgicaL Ablation with MicrowaVe Energy for the Treatment of Atrial Fibrillation), this prospective, randomized trial will enroll 200 patients at up to 40 U.S. and European centers. The trial will evaluate the safety and efficacy of the FLEX Microwave Surgical Ablation System to treat permanent atrial fibrillation patients undergoing mitral valve surgery. Results of the trial may be used to obtain 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. ) approval to treat permanent atrial fibrillation with the technology. "Guidant's sponsorship of the RESOLVE-AF trial demonstrates our commitment to atrial fibrillation therapy," said Maria Degois-Sainz, president, Cardiac Surgery, Guidant Corporation. "We are pleased to partner with leading institutions in the cardiac surgery community to develop treatments for this disabling and life-threatening condition. Guidant's new treatments for atrial fibrillation, including surgical ablation and implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a therapies, are critical components of our larger heart failure strategy and our continued efforts to improve patients' lives and clinical outcomes." "Microwave ablation shows great promise for treating permanent atrial fibrillation, which affects as many as two-thirds of all atrial fibrillation patients," said Michael J. Mack, M.D., director of Transplantation, Medical City Dallas Hospital, Dallas, Texas, cardiovascular/thoracic surgeon and principle investigator of the trial. "I am enthusiastic about the potential of this therapy, which may help expand the treatment options for patients suffering from this condition." About Atrial Fibrillation Atrial fibrillation is a heart arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of that causes the atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. to quiver, preventing the atria from effectively pumping blood into the lower chambers of the heart and reducing pumping efficiency. More than 2.4 million patients in the United States suffer from atrial fibrillation, and its prevalence is expected to double in the next 40 years. The condition can cause heart failure or complicate its effective treatment, and is also associated with reduced quality of life, higher medical costs, and a five-fold increase in the risk of stroke. In approximately 50 percent of atrial fibrillation patients, drug therapy is ineffective or causes severe side effects, making novel therapies, such as surgical ablation, increasingly valuable. About Guidant's Microwave Surgical Ablation System Guidant's FLEX Microwave Surgical Ablation System, composed of a surgical ablation probe and microwave generator, directs microwave energy to targeted tissue to induce cell death. The system typically is used to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise heart tissue during a coronary artery bypass surgery Coronary artery bypass surgery, also coronary artery bypass graft surgery, and colloquially heart bypass or bypass surgery is a surgical procedure performed to relieve angina and reduce the risk of death from coronary artery disease. or mitral valve surgery, but also can be used in minimally invasive, closed-chest procedures. Cleared by the FDA, the Guidant FLEX Microwave Ablation System has been used in more than 8,000 procedures worldwide. In March 2005, the FLEX Microwave Ablation System received Conformite Europeenne (CE) Mark approval in Europe specifically for the treatment of atrial fibrillation, in addition to other cardiac ablation uses. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 12,000 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. For more information visit www.guidant.com. NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. Note to Editors: There should be an accent over the "e" in "Conformite" and an accent over the second "e" in "Europeenne" above. |
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