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 Read the rest of this entry »

Feb 09, 2009 (Datamonitor via COMTEX) –
— 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.
The FDA approval is based on results from a multicenter study comparing catheter ablation to drug therapy Read the rest of this entry »