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American Heart Association News In Brief

This article was originally published in The Gray Sheet

Executive Summary

ThermoCool pre-panel data release: Positive atrial fibrillation results were reported for Johnson & Johnson/Biosense Webster's Navistar ThermoCool irrigated radiofrequency catheter Nov. 11, previewing data that will be put before an FDA advisory panel this week. According to results of a 167-patient, 19-center study presented at the American Heart Association Scientific Sessions in New Orleans by primary investigator David Wilber, Loyola University (Ill.), 62.7% of AF patients treated with Navistar were considered chronic successes after nine months compared to only 17.2% for the group of patients treated with anti-arrhythmic drugs only. Chronic success, the primary endpoint of the study, was defined as freedom from documented symptomatic AF recurrence following procedural success without need for new anti-arrhythmic drugs or further ablation procedures. Also, at 90 days post-procedure, 18.4% of ThermoCool patients had a serious adverse event compared to 35.1% of control patients. The data support Biosense Webster's PMA application for ThermoCool. If approved, it will be the first ablation device FDA-approved specifically for AF. FDA's Circulatory System Devices Panel will review ThermoCool at its Nov. 20 meeting (1"The Gray Sheet" Oct. 20, 2008, p. 7). The device is already FDA-approved to treat Type-1 atrial flutter and ventricular tachycardia
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