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AtriCure begins pivotal trial to evaluate Isolator Synergy bipolar ablation system for AF treatment

AtriCure : 12 February, 2008  (New Product)
The first patient has been successfully treated in AtriCure's Ablate clinical trial with Dr Richard Kaplon, a cardiac surgeon, performing the procedure at Mercy General Hospital in Sacramento, California, USA.
The purpose of the Ablate clinical trial is to evaluate the safety and effectiveness of AtriCure's Isolator Synergy bipolar ablation system for re-establishing normal heart rhythm in patients with permanent atrial fibrillation, or AF, requiring concomitant open-heart surgery utilising the Cox Maze IV procedure.

The Isolator Synergy bipolar ablation system is designed to create precise lesions, or scars, on heart muscle, which block irregular electrical signals and restore normal sinus rhythm.

The prospective, non-randomised clinical trial is expected to enrol approximately 70 patients at 10 medical centres in the USA. The primary efficacy endpoints for the trial are patients being free from AF and off anti-arrhythmic drugs at six months. Upon the completion of a successful trial, the results will be submitted to the FDA as part of a Pre-Market Approval, or PMA, in support of an AF indication for our Isolator Synergy bipolar ablation system when used to treat patients undergoing concomitant open-heart surgery.

Dr Richard Kaplon commented, 'Patients who have AF are at significant risk for stroke and death when compared to patients in normal sinus rhythm. We believe that this is an important treatment for our patients. Based on our group's experience using the Isolator Synergy bipolar ablation system, we believe that the study endpoints are well designed and that the trial plan will facilitate enrolment.'

'According to the American Heart Association, AF is estimated to affect more than 5.5 million people worldwide and is the leading cause of stroke. Due to the lack of AF treatment alternatives, it is important for AtriCure to work closely with the FDA to investigate potentially safer and more effective treatment alternatives for the millions of patients who suffer the debilitating effects of AF,' said David J Drachman, AtriCure's president and chief executive officer. 'We believe that the Ablate clinical trial is another example of our unwavering commitment to build a great and enduring company.'
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