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Surgeons report positive data on the use of AtriCure's minimally invasive ablation system

AtriCure : 15 January, 2008  (New Product)
AtriCure has reported published results on an 83 patient study of AtriCure's Isolator endoscopic bipolar ablation system, which physicians have adopted to treat atrial fibrillation (AF).
The results were published in the Journal of Interventional Cardiac Electrophysiology by two prominent cardiac surgeons, Dr James R Edgerton and Dr Michael B Mack from the Cardiopulmonary Research Science and Technology Institute of Dallas, Texas in collaboration with Dr Warren M Jackman, a prominent electrophysiologist from the University of Oklahoma.

The authors reported the results from 83 patients who underwent a video- assisted, minimally invasive ablation procedure for the treatment of AF using AtriCure's Isolator endoscopic bipolar ablation system. The procedure included electrical isolation of the pulmonary veins, confirmed by electrophysiology mapping techniques, targeted autonomic denervation of the left atrium and the removal of the left atrial appendage in selected patients.

The study population consisted of patients with left atrial enlargement as the authors reported a mean left atrial size of 5.2cm. Left atrial enlargement is known to be one of the primary predictors of ablation failures. Additionally, 25 percent of the patients had at least one previous Catheter ablation failure.

Of the 83 patients, 57 completed long-term monitoring at six months. Treatment success was defined as no episodes of AF greater than 15 seconds in duration. The minimally invasive procedure was successful in 32 of 39 (82 percent) of patients that presented with paroxysmal AF and 10 of 18 (56 percent) of patients that presented with persistent and long-standing persistent AF.

Dr James R Edgerton commented, 'The results from this study are very encouraging and support the safety and effectiveness of this procedure and products in a selected group of AF patients. We remain enthusiastic concerning the continued development and investigation of these minimally invasive products and techniques. In particular, we have developed an expanded ablation procedure and we are encouraged by the potential for the expanded ablation procedure to improve clinical outcomes in the more difficult to treat persistent and permanent AF patients.'

'The use of rigorous, long-term monitoring in a study population of patients who are not ideal candidates for ablation, underscores these encouraging results and reinforces our thesis that AtriCure is well positioned to meet a large and growing demand for safe and effective AF treatment alternatives,' said David J Drachman, AtriCure's president and chief executive officer.

'We are excited about the upcoming launch of our Coolrail Linear Pen ablation system which is designed to be used in conjunction with our endoscopic Isolator bipolar ablation system in order to enhance our results in persistent and permanent patients. Further, we remain committed to pursuing AF approvals for our products from the Food and Drug Administration (FDA).'
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