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Market & Industry Briefs

Brief summaries of recent medtech market and industry developments. This month we cover J&J's and Medtronic's moves in a-fib, Abbott's acquisition of AMO, Northstar Neuroscience's demise and Invatec's European launch of its drug-eluting balloon. Plus a snapshot of ambulatory surgery in the US.

The atrial fibrillation (AF) ablation market got a huge boost early this month when Biosense Webster Inc., a division of Johnson & Johnson (J&J), received final Food & Drug Administration (FDA) marketing approval for its NaviStar ThermoCool and bidirectional EZ Steer ThermoCool Nav irrigated radiofrequency ablation catheters for the treatment of AF. Under the approved indication, the devices can now be marketed in the US for patients with drug refractory, recurrent, symptomatic, paroxysmal AF when used with compatible 3D electroanatomic mapping systems. Conditional to the approval, the company will be required to conduct a postmarketing registry study and a physician education program.

The approval was based on a 167-patient randomized trial conducted at 19 sites worldwide that compared AF ablation with the ThermoCool catheters versus antiarrhythmic drug (AAD) therapy. Those in the...

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