AtriCure Announces Initiation of the ABLATE Pivotal Trial to Evaluate the Isolator Synergy(TM) Bipolar Ablation System to Treat Atrial Fibrillation
The purpose of the ABLATE clinical trial is to evaluate the safety andeffectiveness of AtriCure's Isolator Synergy(TM) bipolar ablation system forreestablishing normal heart rhythm in patients with permanent atrialfibrillation, or AF, requiring concomitant open-heart surgery utilizing theCox Maze IV procedure. The Isolator Synergy(TM) bipolar ablation system isdesigned to create precise lesions, or scars, on heart muscle, which blockirregular electrical signals and restore normal sinus rhythm.
This prospective, non-randomized clinical trial is expected to enrollapproximately 70 patients at 10 medical centers in the United States. Theprimary efficacy endpoints for the trial are patients being free from AF andoff anti-arrhythmic drugs at six months. Upon the completion of a successfultrial, the results will be submitted to the FDA as part of a Pre-MarketApproval, or PMA, in support of an AF indication for our Isolator Synergy(TM)bipolar ablation system when used to treat patients undergoing concomitantopen-heart surgery.
Dr. Richard Kaplon commented, "Patients who have AF are at significantrisk for stroke and death when compared to patients in normal sinus rhythm. Webelieve that this is an important treatment for our patients. Based on ourgroup's experience using the Isolator Synergy(TM) bipolar ablation system, webelieve that the study endpoints are well designed and that the trial planwill facilitate enrollment."
"According to the American Heart Association, AF is estimated to affectmore than 5.5 million people worldwide and is the leading cause of stroke. Dueto the lack of AF treatment alternatives, it is important for AtriCure to workclosely with the FDA to investigate potentially safer and more effectivetreatment alternatives for the millions of patients who suffer thedebilitating effects of AF," said David J. Drachman, AtriCure's President andChief Executive Officer. "We believe that the ABLATE clinical trial is anotherexample of our unwavering commitment to build a great and enduring Company."
About AtriCure, Inc.
AtriCure, Inc. is a medical device company and a leader in developing,manufacturing and selling innovative cardiac surgical ablation systemsdesigned to create precise lesions, or scars, in cardiac, or heart, tissue.Medical journals have described the adoption by leading cardiothoracicsurgeons of the AtriCure Isolator(R) bipolar ablation system as a treatmentalternative during open-heart surgical procedures to create lesions in cardiactissue to block the abnormal electrical impulses that cause atrialfibrillation, or AF, a rapid, irregular quivering of the upper chambers of theheart. Additionally, medical journals and leading cardiothoracic surgeons havedescribed the AtriCure Isolator(R) system as a promising treatment alternativefor patients who may be candidates for sole-therapy minimally invasiveprocedures. AF affects more than 5.5 million people worldwide and predisposesthem to a five-fold increased risk of stroke.
The FDA has cleared the AtriCure Isolator(R) bipolar ablation system,including the new Isolator Synergy(TM) ablation clamps and the AtriCuremultifunctional bipolar Pen, for the ablation, or destruction, of cardiactissue during surgical procedures. Additionally, the FDA has cleared theAtriCure Pen for temporary pacing, sensing, stimulating and recording duringthe evaluation of cardiac arrhythmias. To date, the FDA has not cleared orapproved AtriCure's products for the treatment of AF. AtriCure's left atrialappendage clip system ha
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