Jul 5, 2005
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, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE: GDT) 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. The first patient was enrolled in the trial on June 27, 2005, by John Johnkoski, M.D., cardiothoracic surgeon, at Wausau Hospital in Wausau, Wis.
Called RESOLVE-AF, (RandomizEd 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) 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 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 that causes the atria 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 heart tissue during a coronary artery bypass surgery 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 Conformité Européenne (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.