Washington, February 9:
Johnson and Johnson (JNJ) has finally got a green signal from The Food and Drug Administration (FDA), to market a device that could be a potential cure for the common heart-rhythm disorder called atrial fibrillation. This is the first ever approval given by the FDA for a device of this kind.
The news is welcomed by the already booming device market. As per the estimations made by JPMorgan analyst, Michael Weinstein the Read the rest of this entry »

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 »