J&J Gets Panel Date Seeking First A-Fib Ablation Catheter Indication
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson's chances of becoming the first firm to market an ablation device in the U.S. labeled for treating atrial fibrillation will be clearer next month, when the company is scheduled to present PMA supplement data to an FDA advisory panel
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American Heart Association News In Brief
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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American Heart Association News In Brief
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