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news.Biosense Webster, a Johnson & Johnson company, has received marketing approval from the FDA for its Navistar Thermocool catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
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The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of atrial fibrillation (AFib). In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug therapy for the treatment of drug refractory recurrent symptomatic paroxysmal AFib.
The approval by the FDA also includes the EZ Steer Thermocool navigational catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3-D mapping systems which recognize the Carto system magnetic location sensors. These include the Carto, Carto XP, and Carto 3 EP Navigation Systems, the company said.
The Navistar Thermocool catheter is also approved in the US for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.
Marcia Yaross, vice president of clinical, regulatory and health policy at Biosense Webster, said: This decision by the FDA recognizes the safety and effectiveness of Navistar Thermocool catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.