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Panel recommends FDA approval of ThermoCool ablation catheter
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The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has unanimously voted to recommend the agency approve the NaviStar ThermoCool irrigated radiofrequency ablation catheter.
The panel recommended the NaviStar catheter (Biosense Webster) for the treatment of type 1 atrial flutter in patients aged 18 years or older and also for recurrent drug or device refractory sustained monomorphic ventricular tachycardia due to prior MI in adults. The recommendation was accompanied by several conditions.
One of the conditions was that the ThermoCool unidirectional catheter was to be used with the Carto RMT EP electroanatomical mapping system (Biosense Webster). Other conditions included the addition of a physician education program providing instruction on the use of the catheter system, the development of a registry designed to track patients treated with the catheter and completion of a post-marketing study evaluating long-term outcomes in patients treated with the catheter.
“This will add an important tool to the electrophysiologist's toolkit,” David Slotwiner, MD, a cardiologist at the Long Island Jewish Medical Center, said at the meeting. “It will also allow the sponsor to improve training and spread the use of this catheter, which will be very beneficial for our patients.”
Results from a recent randomized clinical trial of 167 patients suggested that ablation with the ThermoCool catheter reduced recurring paroxysmal atrial fibrillation when compared with antiarrhythmic drugs.